{"id":13184,"date":"2026-02-20T18:52:38","date_gmt":"2026-02-20T18:52:38","guid":{"rendered":"https:\/\/kmslaser.com\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\/"},"modified":"2026-02-20T18:52:38","modified_gmt":"2026-02-20T18:52:38","slug":"que-requisitos-de-la-fda-se-aplican-al-abastecimiento-de-maquinas-de-presoterapia-para-escuelas-de-belleza-de-ee-uu","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/es\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\/","title":{"rendered":"\u00bfQu\u00e9 requisitos de la FDA se aplican al obtener m\u00e1quinas de presoterapia para escuelas de belleza de EE. UU.?"},"content":{"rendered":"<style>article img, .entry-content img, .post-content img, .wp-block-image img, figure img, p img {max-width:100% !important; height:auto !important;}figure { max-width:100%; }img.top-image-square {width:280px; height:280px; object-fit:cover;border-radius:12px; box-shadow:0 2px 12px rgba(0,0,0,0.10);}@media (max-width:600px) {img.top-image-square { width:100%; height:auto; max-height:300px; }p:has(> img.top-image-square) { float:none !important; margin:0 auto 15px auto !important; text-align:center; }}.claim { background-color:#fff4f4; border-left:4px solid #e63946; border-radius:10px; padding:20px 24px; margin:24px 0; font-family:system-ui,sans-serif; line-height:1.6; position:relative; box-shadow:0 2px 6px rgba(0,0,0,0.03); }.claim-true { background-color:#eafaf0; border-left-color:#2ecc71; }.claim-icon { display:inline-block; font-size:18px; color:#e63946; margin-right:10px; vertical-align:middle; }.claim-true .claim-icon { color:#2ecc71; }.claim-title { display:flex; align-items:center; font-weight:600; font-size:16px; color:#222; }.claim-label { margin-left:auto; font-size:12px; background-color:#e63946; color:#fff; padding:3px 10px; border-radius:12px; font-weight:bold; }.claim-true .claim-label { background-color:#2ecc71; }.claim-explanation { margin-top:8px; color:#555; font-size:15px; }.claim-pair { margin:32px 0; }<\/style>\n<p style=\"float: right; margin-left: 15px; margin-bottom: 15px;\">\n  <img decoding=\"async\" style=\"max-width:100%; height:auto;\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771613489933-1.jpg\" alt=\"FDA requirements for sourcing pressotherapy machines for US beauty schools and professional training (ID#1)\" class=\"top-image-square\">\n<\/p>\n<p>We often see US clients struggle with complex compliance rules when ordering our compression systems. Avoiding these regulatory pitfalls is critical for your school&#8217;s liability and reputation.<\/p>\n<p><strong>Pressotherapy machines sourced for US beauty schools are regulated as Class II medical devices requiring FDA 510(k) clearance. Suppliers must prove substantial equivalence to predicate devices under product code 89K, ensure compliance with 21 CFR Part 820 quality standards, and provide verified listing numbers to avoid import detention.<\/strong><\/p>\n<p>Let\u2019s examine the specific steps needed to secure compliant equipment for your educational programs.<\/p>\n<h2>How do I determine the correct FDA medical device classification for my pressotherapy machines?<\/h2>\n<p>Our engineering team reviews <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/determination-intended-use-510k-devices-guidance-cdrh-staff-update-k98-1\" target=\"_blank\" rel=\"noopener noreferrer\">intended use claims<\/a> <sup id=\"ref-1\"><a href=\"#footnote-1\" class=\"footnote-ref\">1<\/a><\/sup> early in development to prevent misclassification risks. If you ignore these definitions, your imported equipment could face immediate border rejection.<\/p>\n<p><strong>You must classify pressotherapy machines based on their intended use and risk level, typically falling under Class II with Product Code 89K for pressure-applying devices. While some simple massagers are Class I, devices making lymphatic drainage or therapeutic claims for schools require 510(k) clearance to demonstrate safety.<\/strong><\/p>\n<p><img decoding=\"async\" style=\"max-width:100%; height:auto;\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771613493039-2.jpg\" alt=\"Determining the correct FDA medical device classification for professional pressotherapy equipment (ID#2)\" title=\"FDA Medical Device Classification\"><\/p>\n<p>Determining the correct classification is the foundation of a legal import strategy. Many buyers assume that because a machine is used in a &quot;beauty&quot; setting, it is exempt from medical regulations. This is a dangerous misconception. In our factory, we design circuits and pressure controls specifically to meet the rigorous standards of <a href=\"https:\/\/www.fda.gov\/medical-devices\/classify-your-medical-device\" target=\"_blank\" rel=\"noopener noreferrer\">Class II devices<\/a> <sup id=\"ref-2\"><a href=\"#footnote-2\" class=\"footnote-ref\">2<\/a><\/sup> because we know the FDA focuses on the <em>mechanism of action<\/em>, not just the setting where the device is used.<\/p>\n<p>For beauty schools, the distinction is vital. You are training students on professional equipment. If that equipment is an unapproved Class III device (which requires rigorous <a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-approval-pma\/premarket-approval-pma\" target=\"_blank\" rel=\"noopener noreferrer\">Premarket Approval<\/a> <sup id=\"ref-3\"><a href=\"#footnote-3\" class=\"footnote-ref\">3<\/a><\/sup>) or a misbranded Class II device, the school assumes massive liability. The FDA categorizes these machines based on <a href=\"https:\/\/www.fda.gov\/medical-devices\/classify-your-medical-device\/product-code-classification-database\" target=\"_blank\" rel=\"noopener noreferrer\">Product Codes<\/a> <sup id=\"ref-4\"><a href=\"#footnote-4\" class=\"footnote-ref\">4<\/a><\/sup>.<\/p>\n<h3>Common Product Codes for Compression Systems<\/h3>\n<p>The table below outlines where most professional pressotherapy systems fit within FDA regulation.<\/p>\n<table>\n<thead>\n<tr>\n<th align=\"left\">Product Code<\/th>\n<th align=\"left\">Device Classification<\/th>\n<th align=\"left\">Common Description<\/th>\n<th align=\"left\">Regulation Number<\/th>\n<th align=\"left\">Requirement<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td align=\"left\"><strong>89K<\/strong><\/td>\n<td align=\"left\">Class II<\/td>\n<td align=\"left\">Pressure Applying Device<\/td>\n<td align=\"left\">21 CFR 890.5650<\/td>\n<td align=\"left\"><strong>510(k) Required<\/strong><\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>89I<\/strong><\/td>\n<td align=\"left\">Class I (Sometimes II)<\/td>\n<td align=\"left\">Measuring\/Therapeutic Massager<\/td>\n<td align=\"left\">21 CFR 890.5660<\/td>\n<td align=\"left\">General Controls (Some Exempt)<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>IPF<\/strong><\/td>\n<td align=\"left\">Class II<\/td>\n<td align=\"left\">Vibrator, Therapeutic<\/td>\n<td align=\"left\">21 CFR 890.5975<\/td>\n<td align=\"left\">510(k) Required<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>The &quot;Intended Use&quot; Trap<\/h3>\n<p>The classification depends heavily on your labeling. If your private label manual claims to &quot;cure obesity&quot; or &quot;treat circulatory disease,&quot; the device might be elevated to Class III, which is virtually impossible to import without millions in clinical trials. For beauty schools, the safe path is sticking to indications cleared for Class II predicates, such as temporary relief of muscle aches, increased local blood circulation, or temporary reduction in the appearance of cellulite (if supported by specific predicates). We advise all our partners to review their marketing materials against the FDA&#39;s database of cleared devices to ensure alignment.<\/p>\n<div class=\"claim-pair\">\n<div class=\"claim claim-true\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2714<\/span> Pressotherapy machines are generally Class II Medical Devices <span class=\"claim-label\">True<\/span><\/div>\n<div class=\"claim-explanation\">Most effective air compression systems for lymphatic work fall under 21 CFR 890.5650 (Code 89K) requiring 510(k).<\/div>\n<\/div>\n<div class=\"claim claim-false\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2718<\/span> Esthetic use exempts machines from FDA rules <span class=\"claim-label\">False<\/span><\/div>\n<div class=\"claim-explanation\">The FDA regulates the device&#8217;s mechanism and claims; use in a salon or school does not bypass medical device laws.<\/div>\n<\/div>\n<\/div>\n<h2>Can my Chinese OEM partner handle the FDA registration and 510(k) process for my private label?<\/h2>\n<p>We guide many brand owners through the documentation maze, but the legal burden often shifts. Relying solely on a factory&#8217;s generic clearance may limit your brand&#8217;s growth potential.<\/p>\n<p><strong>Your Chinese OEM partner can support the process by providing technical testing data and device master files, but the US-based brand owner or initial importer is typically the 510(k) submitter. You must act as the official correspondent to control the listing and ensure your specific private label branding is cleared.<\/strong><\/p>\n<p><img decoding=\"async\" style=\"max-width:100%; height:auto;\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771613494093-3.jpg\" alt=\"Chinese OEM partner handling FDA registration and 510k process for private label beauty machines (ID#3)\" title=\"OEM FDA Registration Process\"><\/p>\n<p>This is one of the most frequently asked questions we receive from Purchasing Managers. The short answer is that while we, as the manufacturer, do the heavy lifting regarding engineering and safety testing, the regulatory strategy depends on who you want to be the &quot;owner&quot; of the market authorization.<\/p>\n<p>If you simply buy our standard model and resell it, you might be able to use our existing 510(k) if we grant you permission to list under our number. However, most serious beauty schools and distributors want to build their own asset. They want the 510(k) in <em>their<\/em> name. In this scenario, we become your contract manufacturer. We provide the device, the technical drawings, the EMC test reports (electromagnetic compatibility), and the safety data. You (or your regulatory consultant) then submit the <a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/510k-submission-process\" target=\"_blank\" rel=\"noopener noreferrer\">510(k) application<\/a> <sup id=\"ref-5\"><a href=\"#footnote-5\" class=\"footnote-ref\">5<\/a><\/sup> to the FDA.<\/p>\n<h3>Roles and Responsibilities in FDA Submission<\/h3>\n<p>Understanding the division of labor is crucial for a smooth launch.<\/p>\n<table>\n<thead>\n<tr>\n<th align=\"left\">Task<\/th>\n<th align=\"left\">OEM Factory (Us)<\/th>\n<th align=\"left\">Brand Owner (You)<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td align=\"left\"><strong>Device Design &amp; Engineering<\/strong><\/td>\n<td align=\"left\">Lead Responsibility<\/td>\n<td align=\"left\">Provides Requirements<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>IEC 60601 Safety Testing<\/strong><\/td>\n<td align=\"left\">Arranges &amp; Pays Lab<\/td>\n<td align=\"left\">Reviews Reports<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>510(k) Submission Fee<\/strong><\/td>\n<td align=\"left\">Support<\/td>\n<td align=\"left\">Pays FDA User Fee<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>Legal 510(k) Holder<\/strong><\/td>\n<td align=\"left\">Optional<\/td>\n<td align=\"left\">Recommended<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>US Agent Representation<\/strong><\/td>\n<td align=\"left\">n\/a<\/td>\n<td align=\"left\">Appoints US Agent<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>Device Listing<\/strong><\/td>\n<td align=\"left\">Contract Manufacturer<\/td>\n<td align=\"left\">Specification Developer<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>The &quot;Traditional&quot; vs. &quot;Abbreviated&quot; Path<\/h3>\n<p>Most pressotherapy devices enter via the &quot;Traditional 510(k)&quot; pathway. This requires proving your device is &quot;substantially equivalent&quot; to a device already legally on the market (a predicate). We assist by identifying suitable predicates\u2014often devices we have previously manufactured or well-known competitor models. We then conduct bench testing to prove that our pressure output, cycle times, and electrical safety match or exceed that predicate. Without this data from your supplier, your application will be rejected &quot;Refuse to Accept&quot; (RTA) immediately.<\/p>\n<div class=\"claim-pair\">\n<div class=\"claim claim-true\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2714<\/span> Private labelers can hold their own 510(k) <span class=\"claim-label\">True<\/span><\/div>\n<div class=\"claim-explanation\">Brand owners often submit as the &#8220;Specification Developer&#8221; to own the clearance asset, using the factory&#8217;s data.<\/div>\n<\/div>\n<div class=\"claim claim-false\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2718<\/span> A factory&#8217;s &#8220;FDA Registration&#8221; equals device clearance <span class=\"claim-label\">False<\/span><\/div>\n<div class=\"claim-explanation\">Registration just means the facility is listed; specific devices still need a 510(k) clearance number (K number).<\/div>\n<\/div>\n<\/div>\n<h2>What specific FDA documentation do I need to clear US Customs when importing beauty school equipment?<\/h2>\n<p>Our logistics team prepares these packets daily to ensure containers aren&#8217;t held at Long Beach. Missing a single code or registration number can cause weeks of expensive delays.<\/p>\n<p><strong>To clear US Customs, you need the manufacturer&#8217;s FDA Establishment Registration number, the specific Device Listing number for the imported model, and a valid 510(k) &#8220;K number.&#8221; Additionally, the commercial invoice must strictly match the product codes declared to the FDA to prevent red-list detention.<\/strong><\/p>\n<p><img decoding=\"async\" style=\"max-width:100%; height:auto;\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771613495463-4.jpg\" alt=\"Essential FDA documentation for clearing US Customs when importing beauty school equipment (ID#4)\" title=\"US Customs FDA Documentation\"><\/p>\n<p>When your shipment arrives at a US port, FDA import reviewers work alongside <a href=\"https:\/\/www.fda.gov\/medical-devices\/importing-medical-devices-and-radiation-emitting-electronic-products-us\" target=\"_blank\" rel=\"noopener noreferrer\">Customs and Border Protection<\/a> <sup id=\"ref-6\"><a href=\"#footnote-6\" class=\"footnote-ref\">6<\/a><\/sup> (CBP). They do not physically inspect every box, but they digitally inspect every document. If the data does not match the FDA&#39;s PREDICT database, your pressotherapy machines will be flagged. We have seen competitors&#39; shipments detained because the product on the invoice (&quot;Lymphatic Drainage Machine&quot;) did not match the product name in the FDA Device Listing.<\/p>\n<h3>The Critical &quot;Red List&quot; Warning<\/h3>\n<p>The FDA maintains &quot;<a href=\"https:\/\/www.fda.gov\/industry\/import-program-fda\/import-alerts\" target=\"_blank\" rel=\"noopener noreferrer\">Import Alerts<\/a> <sup id=\"ref-7\"><a href=\"#footnote-7\" class=\"footnote-ref\">7<\/a><\/sup>,&quot; often referred to as the Red List. This list contains companies and products that are detained without physical examination (DWPE). Pressotherapy devices are frequent targets. If your supplier has ever shipped non-compliant Class III devices or failed to provide a 510(k) when required, they might be on this list. Once on the list, getting off is difficult and costly. Before placing an order, you must verify your supplier&#39;s standing.<\/p>\n<h3>Essential Import Documentation Checklist<\/h3>\n<p>Ensure your supplier provides the following before the goods leave the factory floor.<\/p>\n<table>\n<thead>\n<tr>\n<th align=\"left\">Document \/ Data Point<\/th>\n<th align=\"left\">Why It Is Critical<\/th>\n<th align=\"left\">Where to Verify<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td align=\"left\"><strong>510(k) Premarket Notification Number<\/strong><\/td>\n<td align=\"left\">Proves the device is cleared for sale.<\/td>\n<td align=\"left\">FDA 510(k) Database<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>Establishment Registration No.<\/strong><\/td>\n<td align=\"left\">Proves the factory is registered with the FDA.<\/td>\n<td align=\"left\">FDA Establishment Search<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>Device Listing Number<\/strong><\/td>\n<td align=\"left\">Links the specific model to the manufacturer.<\/td>\n<td align=\"left\">FDA Device Listings<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>Affirmation of Compliance Codes<\/strong><\/td>\n<td align=\"left\">Used by customs brokers to file entry.<\/td>\n<td align=\"left\">ACE System (Broker)<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>Intended Use Labeling<\/strong><\/td>\n<td align=\"left\">Must match the 510(k) clearance exactly.<\/td>\n<td align=\"left\">User Manual \/ Packaging<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Accurate Invoicing is Key<\/h3>\n<p>We emphasize to our partners that the commercial invoice is a legal document. Vague descriptions like &quot;Beauty Equipment&quot; are insufficient for medical devices. The invoice should list the specific model number that matches the Device Listing. Furthermore, the &quot;Value&quot; declared must be accurate. Undervaluing goods to save on duties is fraud, but it also triggers FDA scrutiny if the pricing looks suspicious for a sophisticated medical device. Consistency across all paperwork\u2014from the Bill of Lading to the FDA Device Listing\u2014is your best defense against delays.<\/p>\n<div class=\"claim-pair\">\n<div class=\"claim claim-true\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2714<\/span> Import Alerts block products without physical inspection <span class=\"claim-label\">True<\/span><\/div>\n<div class=\"claim-explanation\">If a supplier is on the Red List (e.g., Alert 89-08), their goods are automatically detained upon arrival.<\/div>\n<\/div>\n<div class=\"claim claim-false\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2718<\/span> CE certification is sufficient for US Customs <span class=\"claim-label\">False<\/span><\/div>\n<div class=\"claim-explanation\">CE marks are for Europe; US Customs requires FDA registration and 510(k) clearance, disregarding CE completely.<\/div>\n<\/div>\n<\/div>\n<h2>How can I ensure my supplier\u2019s manufacturing standards align with FDA safety requirements for US beauty schools?<\/h2>\n<p>We invite clients to audit our assembly lines to see our quality controls in action. Trust is good, but verified documentation of a Quality Management System is safer.<\/p>\n<p><strong>You must verify that your supplier operates under a Quality Management System compliant with 21 CFR Part 820 (Quality System Regulation). Demand proof of ISO 13485 certification, review their electrical safety test reports (IEC 60601-1), and request recent audit results to ensure consistent safety for student use.<\/strong><\/p>\n<p><img decoding=\"async\" style=\"max-width:100%; height:auto;\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771613496579-5.jpg\" alt=\"Ensuring supplier manufacturing standards align with FDA safety requirements for US beauty schools (ID#5)\" title=\"Supplier FDA Safety Standards\"><\/p>\n<p>Sourcing for beauty schools adds a layer of responsibility. Students are learning; they make mistakes. The equipment must be robust and intrinsically safe. The FDA mandates that medical device manufacturers follow Current Good Manufacturing Practices (cGMP), codified in 21 CFR Part 820. This is not just about the final product working; it is about the <em>process<\/em> of making it.<\/p>\n<h3>The Link Between ISO 13485 and FDA QSR<\/h3>\n<p>While the FDA has its own regulation (Part 820), it is harmonizing closely with the international standard ISO 13485. A factory that is ISO 13485 certified is much more likely to be FDA compliant. When you evaluate us or any other supplier, ask for the <a href=\"https:\/\/www.iso.org\/iso-13485-medical-devices.html\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 13485 certificate<\/a> <sup id=\"ref-8\"><a href=\"#footnote-8\" class=\"footnote-ref\">8<\/a><\/sup> issued by a reputable registrar (like SGS, TUV, or Intertek). This certificate proves we have procedures for design controls, risk management, and complaint handling.<\/p>\n<h3>Safety Testing You Cannot Skip<\/h3>\n<p>For pressotherapy, the biggest risks are electrical shock and over-pressurization (which can cause injury).<\/p>\n<ul>\n<li><strong>IEC 60601-1:<\/strong> This is the general standard for medical electrical equipment safety.<\/li>\n<li><strong>IEC 60601-1-2:<\/strong> This covers electromagnetic compatibility (EMC). It ensures the machine won&#39;t interfere with other electronics in the school and won&#39;t be disrupted by them.<\/li>\n<li><strong>Software Validation:<\/strong> Modern pressotherapy machines use software to control compression cycles. FDA requires &quot;Software Validation&quot; documentation to prove the code won&#39;t fail dangerously.<\/li>\n<\/ul>\n<p>If a supplier cannot produce these test reports from an accredited lab, walk away. A &quot;CE Certificate&quot; from a questionable notified body is not a substitute for a full IEC 60601 test report when facing US liability laws.<\/p>\n<h3>Continuous Quality Monitoring<\/h3>\n<p>Compliance does not end at shipping. FDA regulations require manufacturers to monitor complaints. If a student at your school claims the machine squeezed too hard and caused bruising, this is an adverse event. Your supplier must have a system to log this complaint, investigate the root cause, and implement a corrective action (CAPA). We maintain a digital portal for our partners to log such issues, ensuring we both stay compliant with FDA reporting requirements (MDR).<\/p>\n<div class=\"claim-pair\">\n<div class=\"claim claim-true\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2714<\/span> FDA audits foreign manufacturers <span class=\"claim-label\">True<\/span><\/div>\n<div class=\"claim-explanation\">The FDA inspects Chinese factories to ensure 21 CFR 820 compliance; failure leads to Warning Letters.<\/div>\n<\/div>\n<div class=\"claim claim-false\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2718<\/span> A working prototype proves manufacturing quality <span class=\"claim-label\">False<\/span><\/div>\n<div class=\"claim-explanation\">A prototype works once; FDA QSR ensures every single unit off the line is safe and identical to the cleared design.<\/div>\n<\/div>\n<\/div>\n<h2>Conclusion<\/h2>\n<p>Sourcing pressotherapy machines for US beauty schools requires navigating complex FDA Class II regulations, 510(k) clearances, and strict import documentation. By partnering with a manufacturer who understands 21 CFR Part 820 and provides transparent compliance data, you protect your students and business.<\/p>\n<h2>Footnotes<\/h2>\n<p><span id=\"footnote-1\"><br \/>\n1. Official FDA guidance on determining the intended use of medical devices. <a href=\"#ref-1\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-2\"><br \/>\n2. Provides official FDA information on medical device classification and controls. <a href=\"#ref-2\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-3\"><br \/>\n3. Explains the FDA&#8217;s most rigorous review process for high-risk Class III devices. <a href=\"#ref-3\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-4\"><br \/>\n4. Direct link to the FDA database for medical device product codes. <a href=\"#ref-4\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-5\"><br \/>\n5. Outlines the steps and requirements for a 510(k) premarket notification submission. <a href=\"#ref-5\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-6\"><br \/>\n6. Details the collaboration between FDA and CBP for medical device imports. <a href=\"#ref-6\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-7\"><br \/>\n7. Provides official FDA information on Import Alerts and their purpose. <a href=\"#ref-7\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-8\"><br \/>\n8. Explains the international standard for quality management systems in medical devices. <a href=\"#ref-8\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"FAQPage\",\n  \"mainEntity\": [\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What FDA Requirements Apply When Sourcing Pressotherapy Machines for US Beauty Schools?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Pressotherapy machines sourced for US beauty schools are regulated as Class II medical devices requiring FDA 510(k) clearance. Suppliers must prove substantial equivalence to predicate devices under product code 89K, ensure compliance with 21 CFR Part 820 quality standards, and provide verified listing numbers to avoid import detention.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"How do I determine the correct FDA medical device classification for my pressotherapy machines?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"You must classify pressotherapy machines based on their intended use and risk level, typically falling under Class II with Product Code 89K for pressure-applying devices. While some simple massagers are Class I, devices making lymphatic drainage or therapeutic claims for schools require 510(k) clearance to demonstrate safety.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Can my Chinese OEM partner handle the FDA registration and 510(k) process for my private label?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Your Chinese OEM partner can support the process by providing technical testing data and device master files, but the US-based brand owner or initial importer is typically the 510(k) submitter. You must act as the official correspondent to control the listing and ensure your specific private label branding is cleared.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What specific FDA documentation do I need to clear US Customs when importing beauty school equipment?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"To clear US Customs, you need the manufacturer's FDA Establishment Registration number, the specific Device Listing number for the imported model, and a valid 510(k) \\\"K number.\\\" Additionally, the commercial invoice must strictly match the product codes declared to the FDA to prevent red-list detention.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"How can I ensure my supplier\u2019s manufacturing standards align with FDA safety requirements for US beauty schools?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"You must verify that your supplier operates under a Quality Management System compliant with 21 CFR Part 820 (Quality System Regulation). Demand proof of ISO 13485 certification, review their electrical safety test reports (IEC 60601-1), and request recent audit results to ensure consistent safety for student use.\"\n      }\n    }\n  ]\n}\n<\/script><\/p>\n<p><script type=\"application\/ld+json\">\n[\n  {\n    \"@context\": \"https:\/\/schema.org\",\n    \"@type\": \"ClaimReview\",\n    \"url\": \"\",\n    \"claimReviewed\": \"Pressotherapy machines are generally Class II Medical Devices\",\n    \"author\": {\n      \"@type\": \"Organization\",\n      \"name\": \"Article Author\"\n    },\n    \"reviewRating\": {\n      \"@type\": \"Rating\",\n      \"ratingValue\": 5,\n      \"bestRating\": 5,\n      \"worstRating\": 1,\n      \"alternateName\": \"True\"\n    }\n  },\n  {\n    \"@context\": \"https:\/\/schema.org\",\n    \"@type\": \"ClaimReview\",\n    \"url\": \"\",\n    \"claimReviewed\": \"Esthetic use exempts machines from FDA rules\",\n    \"author\": {\n      \"@type\": \"Organization\",\n      \"name\": \"Article Author\"\n    },\n    \"reviewRating\": {\n      \"@type\": \"Rating\",\n      \"ratingValue\": 1,\n      \"bestRating\": 5,\n      \"worstRating\": 1,\n      \"alternateName\": \"False\"\n    }\n  },\n  {\n    \"@context\": \"https:\/\/schema.org\",\n    \"@type\": \"ClaimReview\",\n    \"url\": \"\",\n    \"claimReviewed\": \"Private labelers can hold their own 510(k)\",\n    \"author\": {\n      \"@type\": \"Organization\",\n      \"name\": \"Article Author\"\n    },\n    \"reviewRating\": {\n      \"@type\": \"Rating\",\n      \"ratingValue\": 5,\n      \"bestRating\": 5,\n      \"worstRating\": 1,\n      \"alternateName\": \"True\"\n    }\n  },\n  {\n    \"@context\": \"https:\/\/schema.org\",\n    \"@type\": \"ClaimReview\",\n    \"url\": \"\",\n    \"claimReviewed\": \"A factory's \\\"FDA Registration\\\" equals device clearance\",\n    \"author\": {\n      \"@type\": \"Organization\",\n      \"name\": \"Article Author\"\n    },\n    \"reviewRating\": {\n      \"@type\": \"Rating\",\n      \"ratingValue\": 1,\n      \"bestRating\": 5,\n      \"worstRating\": 1,\n      \"alternateName\": \"False\"\n    }\n  },\n  {\n    \"@context\": \"https:\/\/schema.org\",\n    \"@type\": \"ClaimReview\",\n    \"url\": \"\",\n    \"claimReviewed\": \"Import Alerts block products without physical inspection\",\n    \"author\": {\n      \"@type\": \"Organization\",\n      \"name\": \"Article Author\"\n    },\n    \"reviewRating\": {\n      \"@type\": \"Rating\",\n      \"ratingValue\": 5,\n      \"bestRating\": 5,\n      \"worstRating\": 1,\n      \"alternateName\": \"True\"\n    }\n  },\n  {\n    \"@context\": \"https:\/\/schema.org\",\n    \"@type\": \"ClaimReview\",\n    \"url\": \"\",\n    \"claimReviewed\": \"CE certification is sufficient for US Customs\",\n    \"author\": {\n      \"@type\": \"Organization\",\n      \"name\": \"Article Author\"\n    },\n    \"reviewRating\": {\n      \"@type\": \"Rating\",\n      \"ratingValue\": 1,\n      \"bestRating\": 5,\n      \"worstRating\": 1,\n      \"alternateName\": \"False\"\n    }\n  },\n  {\n    \"@context\": \"https:\/\/schema.org\",\n    \"@type\": \"ClaimReview\",\n    \"url\": \"\",\n    \"claimReviewed\": \"FDA audits foreign manufacturers\",\n    \"author\": {\n      \"@type\": \"Organization\",\n      \"name\": \"Article Author\"\n    },\n    \"reviewRating\": {\n      \"@type\": \"Rating\",\n      \"ratingValue\": 5,\n      \"bestRating\": 5,\n      \"worstRating\": 1,\n      \"alternateName\": \"True\"\n    }\n  },\n  {\n    \"@context\": \"https:\/\/schema.org\",\n    \"@type\": \"ClaimReview\",\n    \"url\": \"\",\n    \"claimReviewed\": \"A working prototype proves manufacturing quality\",\n    \"author\": {\n      \"@type\": \"Organization\",\n      \"name\": \"Article Author\"\n    },\n    \"reviewRating\": {\n      \"@type\": \"Rating\",\n      \"ratingValue\": 1,\n      \"bestRating\": 5,\n      \"worstRating\": 1,\n      \"alternateName\": \"False\"\n    }\n  }\n]\n<\/script><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Las m\u00e1quinas de presoterapia obtenidas para escuelas de belleza de EE. UU. se regulan como dispositivos m\u00e9dicos de Clase II que requieren la autorizaci\u00f3n 510(k) de la FDA. Los proveedores deben demostrar\u2026<\/p>","protected":false},"author":3,"featured_media":13179,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[169],"tags":[],"class_list":["post-13184","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pressotherapy-machine"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>What FDA Requirements Apply When Sourcing Pressotherapy Machines for US Beauty Schools? - KMSLaser<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kmslaser.com\/es\/que-requisitos-de-la-fda-se-aplican-al-abastecimiento-de-maquinas-de-presoterapia-para-escuelas-de-belleza-de-ee-uu\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What FDA Requirements Apply When Sourcing Pressotherapy Machines for US Beauty Schools?\" \/>\n<meta property=\"og:description\" content=\"Pressotherapy machines sourced for US beauty schools are regulated as Class II medical devices requiring FDA 510(k) clearance. Suppliers must prove substanti...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/kmslaser.com\/es\/que-requisitos-de-la-fda-se-aplican-al-abastecimiento-de-maquinas-de-presoterapia-para-escuelas-de-belleza-de-ee-uu\/\" \/>\n<meta property=\"og:site_name\" content=\"KMSLaser\" \/>\n<meta property=\"article:published_time\" content=\"2026-02-20T18:52:38+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771613489933-1.jpg\" \/>\n<meta name=\"author\" content=\"Sophia Wu\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Sophia Wu\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"10 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\\\/\"},\"author\":{\"name\":\"Sophia Wu\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#\\\/schema\\\/person\\\/c37fe1d989e6bd9dbe4f1f7b6cfa9588\"},\"headline\":\"What FDA Requirements Apply When Sourcing Pressotherapy Machines for US Beauty Schools?\",\"datePublished\":\"2026-02-20T18:52:38+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\\\/\"},\"wordCount\":2075,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/v2-article-1771613489933-1.jpg\",\"articleSection\":[\"Pressotherapy Machine\"],\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/kmslaser.com\\\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\\\/\",\"url\":\"https:\\\/\\\/kmslaser.com\\\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\\\/\",\"name\":\"What FDA Requirements Apply When Sourcing Pressotherapy Machines for US Beauty Schools? - KMSLaser\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/v2-article-1771613489933-1.jpg\",\"datePublished\":\"2026-02-20T18:52:38+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\\\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/kmslaser.com\\\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\\\/#primaryimage\",\"url\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/v2-article-1771613489933-1.jpg\",\"contentUrl\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/v2-article-1771613489933-1.jpg\",\"width\":1200,\"height\":800},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/kmslaser.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"What FDA Requirements Apply When Sourcing Pressotherapy Machines for US Beauty Schools?\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#website\",\"url\":\"https:\\\/\\\/kmslaser.com\\\/\",\"name\":\"KMSLaser\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/kmslaser.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#organization\",\"name\":\"KMSLaser\",\"url\":\"https:\\\/\\\/kmslaser.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2020\\\/02\\\/logo.png\",\"contentUrl\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2020\\\/02\\\/logo.png\",\"width\":180,\"height\":71,\"caption\":\"KMSLaser\"},\"image\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#\\\/schema\\\/person\\\/c37fe1d989e6bd9dbe4f1f7b6cfa9588\",\"name\":\"Sophia Wu\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g\",\"caption\":\"Sophia Wu\"},\"url\":\"https:\\\/\\\/kmslaser.com\\\/es\\\/author\\\/sophia\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"\u00bfQu\u00e9 requisitos de la FDA se aplican al adquirir m\u00e1quinas de presoterapia para escuelas de belleza de EE. UU.? - KMSLaser","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/kmslaser.com\/es\/que-requisitos-de-la-fda-se-aplican-al-abastecimiento-de-maquinas-de-presoterapia-para-escuelas-de-belleza-de-ee-uu\/","og_locale":"es_MX","og_type":"article","og_title":"What FDA Requirements Apply When Sourcing Pressotherapy Machines for US Beauty Schools?","og_description":"Pressotherapy machines sourced for US beauty schools are regulated as Class II medical devices requiring FDA 510(k) clearance. Suppliers must prove substanti...","og_url":"https:\/\/kmslaser.com\/es\/que-requisitos-de-la-fda-se-aplican-al-abastecimiento-de-maquinas-de-presoterapia-para-escuelas-de-belleza-de-ee-uu\/","og_site_name":"KMSLaser","article_published_time":"2026-02-20T18:52:38+00:00","og_image":[{"url":"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771613489933-1.jpg","type":"","width":"","height":""}],"author":"Sophia Wu","twitter_card":"summary_large_image","twitter_misc":{"Escrito por":"Sophia Wu","Tiempo de lectura":"10 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/kmslaser.com\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\/#article","isPartOf":{"@id":"https:\/\/kmslaser.com\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\/"},"author":{"name":"Sophia Wu","@id":"https:\/\/kmslaser.com\/#\/schema\/person\/c37fe1d989e6bd9dbe4f1f7b6cfa9588"},"headline":"What FDA Requirements Apply When Sourcing Pressotherapy Machines for US Beauty Schools?","datePublished":"2026-02-20T18:52:38+00:00","mainEntityOfPage":{"@id":"https:\/\/kmslaser.com\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\/"},"wordCount":2075,"commentCount":0,"publisher":{"@id":"https:\/\/kmslaser.com\/#organization"},"image":{"@id":"https:\/\/kmslaser.com\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\/#primaryimage"},"thumbnailUrl":"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771613489933-1.jpg","articleSection":["Pressotherapy Machine"],"inLanguage":"es","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/kmslaser.com\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/kmslaser.com\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\/","url":"https:\/\/kmslaser.com\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\/","name":"\u00bfQu\u00e9 requisitos de la FDA se aplican al adquirir m\u00e1quinas de presoterapia para escuelas de belleza de EE. UU.? - KMSLaser","isPartOf":{"@id":"https:\/\/kmslaser.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/kmslaser.com\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\/#primaryimage"},"image":{"@id":"https:\/\/kmslaser.com\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\/#primaryimage"},"thumbnailUrl":"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771613489933-1.jpg","datePublished":"2026-02-20T18:52:38+00:00","breadcrumb":{"@id":"https:\/\/kmslaser.com\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\/#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/kmslaser.com\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/kmslaser.com\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\/#primaryimage","url":"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771613489933-1.jpg","contentUrl":"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771613489933-1.jpg","width":1200,"height":800},{"@type":"BreadcrumbList","@id":"https:\/\/kmslaser.com\/what-fda-requirements-apply-sourcing-pressotherapy-machines-us-beauty-schools\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/kmslaser.com\/"},{"@type":"ListItem","position":2,"name":"What FDA Requirements Apply When Sourcing Pressotherapy Machines for US Beauty Schools?"}]},{"@type":"WebSite","@id":"https:\/\/kmslaser.com\/#website","url":"https:\/\/kmslaser.com\/","name":"KMSLaser","description":"","publisher":{"@id":"https:\/\/kmslaser.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/kmslaser.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Organization","@id":"https:\/\/kmslaser.com\/#organization","name":"KMSLaser","url":"https:\/\/kmslaser.com\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/kmslaser.com\/#\/schema\/logo\/image\/","url":"https:\/\/kmslaser.com\/wp-content\/uploads\/2020\/02\/logo.png","contentUrl":"https:\/\/kmslaser.com\/wp-content\/uploads\/2020\/02\/logo.png","width":180,"height":71,"caption":"KMSLaser"},"image":{"@id":"https:\/\/kmslaser.com\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/kmslaser.com\/#\/schema\/person\/c37fe1d989e6bd9dbe4f1f7b6cfa9588","name":"Sophia Wu","image":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/secure.gravatar.com\/avatar\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g","caption":"Sophia Wu"},"url":"https:\/\/kmslaser.com\/es\/author\/sophia\/"}]}},"_links":{"self":[{"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/posts\/13184","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/comments?post=13184"}],"version-history":[{"count":0,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/posts\/13184\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/media\/13179"}],"wp:attachment":[{"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/media?parent=13184"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/categories?post=13184"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/tags?post=13184"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}