{"id":12346,"date":"2026-02-17T10:52:40","date_gmt":"2026-02-17T10:52:40","guid":{"rendered":"https:\/\/kmslaser.com\/what-us-fda-registration-requirements-buying-pressotherapy-machine\/"},"modified":"2026-02-17T10:52:40","modified_gmt":"2026-02-17T10:52:40","slug":"was-sind-die-fda-registrierungsanforderungen-fur-den-kauf-einer-pressotherapie-maschine","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/de\/what-us-fda-registration-requirements-buying-pressotherapy-machine\/","title":{"rendered":"Welche US-FDA-Registrierungsanforderungen gelten beim Kauf einer Pressotherapie-Maschine?"},"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-1771325479270-1.jpg\" alt=\"US FDA registration requirements for purchasing a professional pressotherapy machine (ID#1)\" class=\"top-image-square\">\n<\/p>\n<p>Every week, our customer service team fields calls from U.S. importers confused by conflicting claims about FDA requirements for pressotherapy equipment. Some suppliers promise &#8220;FDA approved&#8221; devices. Others show registration certificates. The confusion often leads to costly customs delays and compliance headaches.<\/p>\n<p><strong>When buying a pressotherapy machine for the US market, buyers must verify the device has valid FDA 510(k) clearance if classified as Class II, confirm the foreign manufacturer&#8217;s establishment registration with a designated US agent, and ensure proper device listing under 21 CFR Part 807\u2014registration alone does not guarantee device safety or efficacy.<\/strong><\/p>\n<p>This guide breaks down the exact FDA requirements you need to understand before importing pressotherapy equipment. We will cover clearance versus registration, verification methods, OEM responsibilities, and customs documentation.<\/p>\n<h2>How do I determine if my pressotherapy machine requires FDA 510(k) clearance or just facility registration?<\/h2>\n<p>When we develop new pressotherapy models at our facility, the first question our regulatory team addresses is classification. This single determination shapes the entire compliance pathway. Many buyers assume all pressotherapy devices follow the same rules. They do not.<\/p>\n<p><strong>Pressotherapy machines typically fall under Class II medical devices, requiring FDA 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. Class I exempt devices only need facility registration and listing. The device&#39;s intended use and risk level determine which pathway applies\u2014contact FDA directly if classification is unclear.<\/strong><\/p>\n<p><img decoding=\"async\" style=\"max-width:100%; height:auto;\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771325480141-2.jpg\" alt=\"Determining FDA 510(k) clearance versus facility registration for Class II pressotherapy devices (ID#2)\" title=\"FDA 510(k) Clearance Determination\"><\/p>\n<h3>Understanding FDA Device Classification<\/h3>\n<p>Class I includes devices with the lowest risk and Class III includes those with the greatest risk. For pressotherapy machines, classification depends on the device&#39;s intended use, features, and potential risks.<\/p>\n<p>Class I or low risk devices are subject to so called <a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/regulatory-controls#general\" target=\"_blank\" rel=\"noopener noreferrer\">general controls<\/a> <sup id=\"ref-1\"><a href=\"#footnote-1\" class=\"footnote-ref\">1<\/a><\/sup>, such as current good manufacturing practices based upon a quality system, device registration and listing, premarket notification, and other basic regulatory tools. Class II or moderate-risk devices such as magnetic resonance imaging scanners or intravenous medication infusion pumps necessitate pre-market notification and require <a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/regulatory-controls#special\" target=\"_blank\" rel=\"noopener noreferrer\">special controls<\/a> <sup id=\"ref-2\"><a href=\"#footnote-2\" class=\"footnote-ref\">2<\/a><\/sup> such as meeting FDA-recognized performance standards or certain post-market surveillance requirements.<\/p>\n<h3>The Critical Difference: Registration vs. Clearance<\/h3>\n<table>\n<thead>\n<tr>\n<th>Requirement<\/th>\n<th>FDA Registration<\/th>\n<th><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/premarket-notification-510k\" target=\"_blank\" rel=\"noopener noreferrer\">FDA 510(k) Clearance<\/a> <sup id=\"ref-3\"><a href=\"#footnote-3\" class=\"footnote-ref\">3<\/a><\/sup><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>What it means<\/td>\n<td>Facility is recorded in FDA database<\/td>\n<td>Device reviewed for safety\/efficacy<\/td>\n<\/tr>\n<tr>\n<td>Safety evaluation<\/td>\n<td>No<\/td>\n<td>Yes<\/td>\n<\/tr>\n<tr>\n<td>Required for<\/td>\n<td>All manufacturers\/importers<\/td>\n<td>Most Class II devices<\/td>\n<\/tr>\n<tr>\n<td>Annual fee (FY 2026)<\/td>\n<td>$11,423<\/td>\n<td>Separate submission fee<\/td>\n<\/tr>\n<tr>\n<td>Processing time<\/td>\n<td>Days<\/td>\n<td>142-180 days average<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Any establishment involved in the production, importation, reprocessing\/relabeling, or developing specifications of a medical device or IVD for commercial sale in the United States must register annually with the US Food and Drug Administration. This is called &quot;<a href=\"https:\/\/www.fda.gov\/medical-devices\/device-registration-and-listing\/who-must-register-list-and-pay-fee\" target=\"_blank\" rel=\"noopener noreferrer\">Establishment Registration<\/a> <sup id=\"ref-4\"><a href=\"#footnote-4\" class=\"footnote-ref\">4<\/a><\/sup>&quot; and it is a separate process from obtaining 510(k) clearance or PMA approval.<\/p>\n<h3>Key Indicators Your Device Needs 510(k)<\/h3>\n<p>Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a <a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/premarket-approval-pma\" target=\"_blank\" rel=\"noopener noreferrer\">Premarket Approval application (PMA)<\/a> <sup id=\"ref-5\"><a href=\"#footnote-5\" class=\"footnote-ref\">5<\/a><\/sup> is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements.<\/p>\n<p>A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.<\/p>\n<p>Ask yourself:<\/p>\n<ul>\n<li>Does the device make medical claims for lymphatic drainage or edema treatment?<\/li>\n<li>Does it include advanced software for treatment protocols?<\/li>\n<li>Is it marketed for clinical or medical use?<\/li>\n<\/ul>\n<p>If yes, 510(k) clearance is almost certainly required.<\/p>\n<h3>What 510(k) Exempt Means<\/h3>\n<p>Some medical devices are not required to undergo the traditional 510(k) submission process to obtain clearance from the FDA before marketing in the US. Devices that are considered low risk typically have well established safety profiles and do not present significant risks to patients; these devices may qualify for exemption.<\/p>\n<p>If the device is exempt from submitting a 510(k), it still needs to comply with applicable regulatory requirements in accordance with FDA guidelines, such as <a href=\"https:\/\/www.fda.gov\/medical-devices\/device-labeling\/general-device-labeling-requirements\" target=\"_blank\" rel=\"noopener noreferrer\">medical device labeling<\/a> <sup id=\"ref-6\"><a href=\"#footnote-6\" class=\"footnote-ref\">6<\/a><\/sup>, good manufacturing processes (GMPs), quality systems, and post-market surveillance.<\/p>\n<div class=\"claim-pair\">\n<div class=\"claim claim-true\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2714<\/span> A Class II pressotherapy device marketed for medical lymphatic drainage treatment requires 510(k) clearance before US sale <span class=\"claim-label\">True<\/span><\/div>\n<div class=\"claim-explanation\">FDA requires premarket notification (510(k)) for <a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/regulatory-controls#class2\" target=\"_blank\" rel=\"noopener noreferrer\">Class II medical devices<\/a> <sup id=\"ref-7\"><a href=\"#footnote-7\" class=\"footnote-ref\">7<\/a><\/sup> to demonstrate substantial equivalence to a legally marketed <a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-notification-510k\/how-find-and-effectively-use-predicate-devices\" target=\"_blank\" rel=\"noopener noreferrer\">predicate device<\/a> <sup id=\"ref-8\"><a href=\"#footnote-8\" class=\"footnote-ref\">8<\/a><\/sup> before commercial distribution.<\/div>\n<\/div>\n<div class=\"claim claim-false\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2718<\/span> FDA establishment registration means the device has been tested and approved as safe <span class=\"claim-label\">False<\/span><\/div>\n<div class=\"claim-explanation\">Registration only records the facility in FDA&#8217;s database. It does not evaluate device safety or effectiveness\u2014only 510(k) clearance or PMA approval involves such review.<\/div>\n<\/div>\n<\/div>\n<h2>How can I verify that my Chinese manufacturer&#39;s FDA registration is valid for the specific pressotherapy models I&#39;m importing?<\/h2>\n<p>In our experience exporting to the US market, verification confusion causes more shipment delays than any other issue. Buyers often accept registration certificates at face value without checking the actual FDA database. This mistake can leave products stranded at customs.<\/p>\n<p><strong>To verify a Chinese manufacturer&#39;s FDA registration validity, search the FDA Establishment Registration database using the firm name or registration number, then cross-reference by requesting the Device Listing Number directly from the manufacturer\u2014this number links specific models to the registered facility and confirms proper listing under 21 CFR Part 807.<\/strong><\/p>\n<p><img decoding=\"async\" style=\"max-width:100%; height:auto;\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771325481006-3.jpg\" alt=\"Verifying Chinese manufacturer FDA registration and device listing numbers for imported pressotherapy models (ID#3)\" title=\"Verifying Manufacturer FDA Registration\"><\/p>\n<h3>Step-by-Step Verification Process<\/h3>\n<p>When an entry is transmitted to the FDA, we verify that the declared manufacturer and shipper are registered with the FDA by comparing the submitted information with CDRH&#39;s establishment registration and listing database. We also use CDRH&#39;s data system to verify that the declared importer is registered.<\/p>\n<p>Your verification should follow this same process:<\/p>\n<ol>\n<li><strong>Check establishment registration<\/strong>: Use FDA&#39;s online database to confirm the manufacturer is currently registered<\/li>\n<li><strong>Request listing number<\/strong>: You may search the medical device registration and listing database for registration information for any medical device firm that is registered with the FDA. In order to obtain the listing number, you will have to contact the firm that listed the device.<\/li>\n<li><strong>Verify 510(k) clearance<\/strong>: Search the FDA 510(k) database for the specific device<\/li>\n<\/ol>\n<h3>What to Request from Your Supplier<\/h3>\n<table>\n<thead>\n<tr>\n<th>Document<\/th>\n<th>Purpose<\/th>\n<th>Where to Verify<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Registration Number<\/td>\n<td>Confirms facility is registered<\/td>\n<td>FDA Establishment Database<\/td>\n<\/tr>\n<tr>\n<td>Device Listing Number<\/td>\n<td>Links specific products to registration<\/td>\n<td>Request from manufacturer<\/td>\n<\/tr>\n<tr>\n<td>510(k) Clearance Letter<\/td>\n<td>Proves device cleared for market<\/td>\n<td>FDA 510(k) Database<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/www.fda.gov\/medical-devices\/device-registration-and-listing\/us-agents\" target=\"_blank\" rel=\"noopener noreferrer\">US Agent<\/a> <sup id=\"ref-9\"><a href=\"#footnote-9\" class=\"footnote-ref\">9<\/a><\/sup> Information<\/td>\n<td>Required for foreign manufacturers<\/td>\n<td>FDA Registration Records<\/td>\n<\/tr>\n<tr>\n<td>Product Code<\/td>\n<td>Identifies device classification<\/td>\n<td>FDA Product Classification Database<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Foreign Manufacturer Requirements<\/h3>\n<p>The official correspondent for the foreign establishment shall facilitate communication between the foreign establishment&#39;s management and representatives of FDA for matters relating to the registration of device establishments and the listing of device products. Each foreign establishment required to register shall submit the name, address, and phone number of its United States agent as part of its initial and updated registration information. Each foreign establishment shall designate only one United States agent and may designate the United States agent to act as its official correspondent.<\/p>\n<p>All medical device firms outside the U.S. must appoint a U.S. agent as the FDA&#39;s primary point of contact.<\/p>\n<h3>Consequences of Non-Verification<\/h3>\n<p>If the information submitted matches the CDRH establishment registration and listing database, then compliance is verified; if the information does not match, the FDA may gather additional information or may detain the product. If a firm lacks the required registration and listing, the product will be subject to refusal.<\/p>\n<h3>Registration vs. Listing: Why Both Matter<\/h3>\n<p>Registered establishments must list each of their medical devices individually through the FDA Device Listing process before distributing them commercially in the U.S. market. Without a valid establishment registration and device listing number, medical devices cannot be legally marketed in the United States.<\/p>\n<div class=\"claim-pair\">\n<div class=\"claim claim-true\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2714<\/span> Foreign manufacturers must designate a US agent who resides or maintains a place of business in the United States <span class=\"claim-label\">True<\/span><\/div>\n<div class=\"claim-explanation\">FDA regulations under 21 CFR Part 807 require every foreign medical device establishment to designate a single US agent for FDA communications.<\/div>\n<\/div>\n<div class=\"claim claim-false\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2718<\/span> If a manufacturer shows a valid registration certificate, all their products are automatically approved for US import <span class=\"claim-label\">False<\/span><\/div>\n<div class=\"claim-explanation\">Registration applies to the facility, not individual products. Each device model must be separately listed, and Class II devices need individual 510(k) clearance.<\/div>\n<\/div>\n<\/div>\n<h2>If I use an OEM service to private-label my pressotherapy machines, what are my responsibilities for FDA listing?<\/h2>\n<p>Our team works with many US brands who want their name on pressotherapy equipment. They often assume the Chinese manufacturer handles all FDA obligations. This is partially true\u2014but critical responsibilities fall on the US brand owner.<\/p>\n<p><strong>When private-labeling pressotherapy machines through OEM service, you must ensure all brand names appear in the FDA device listing, comply with UDI labeling requirements as the &quot;labeler&quot; since your name is on the product, and establish a quality agreement specifying complaint handling and recall responsibilities\u2014the original manufacturer retains 510(k) holder obligations.<\/strong><\/p>\n<p><img decoding=\"async\" style=\"max-width:100%; height:auto;\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771325481851-4.jpg\" alt=\"FDA listing responsibilities and UDI labeling for private-label OEM pressotherapy machine services (ID#4)\" title=\"OEM Private Label Responsibilities\"><\/p>\n<h3>How Private Label Arrangements Work with FDA<\/h3>\n<p>There is no formal process for &quot;getting a private label.&quot; The entire private label process is negotiated between the distributor and the OEM with no involvement of the FDA. However, in the listing of devices within the FDA FURLS database, all brand names of the device must be identified.<\/p>\n<h3>Your Responsibilities as a Private Label Distributor<\/h3>\n<table>\n<thead>\n<tr>\n<th>Responsibility<\/th>\n<th>Your Obligation<\/th>\n<th>Manufacturer&#39;s Obligation<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>510(k) Clearance<\/td>\n<td>Verify exists<\/td>\n<td>Submit and maintain<\/td>\n<\/tr>\n<tr>\n<td>Brand Name Listing<\/td>\n<td>Ensure listed in FURLS<\/td>\n<td>Submit listing with all names<\/td>\n<\/tr>\n<tr>\n<td>UDI Compliance<\/td>\n<td>Assign DI portion<\/td>\n<td>Apply UDI to labels<\/td>\n<\/tr>\n<tr>\n<td>Complaint Handling<\/td>\n<td>Forward to manufacturer<\/td>\n<td>Investigate root cause<\/td>\n<\/tr>\n<tr>\n<td>Recall Execution<\/td>\n<td>Cooperate<\/td>\n<td>Execute and report<\/td>\n<\/tr>\n<tr>\n<td>FDA Inspections<\/td>\n<td>Limited exposure<\/td>\n<td>Primary establishment<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Quality Agreement Essentials<\/h3>\n<p>The quality agreement must specify which company is responsible for complaint handling and medical device reporting. In this situation, the OEM is the specification developer, as defined by the FDA. Therefore, the OEM will be responsible for reporting and execution of recalls. Therefore, even if the distributor with a private label agreement is identified as the &quot;complaint file establishment,&quot; the OEM will still need to obtain copies of the complaint information from the distributor, and determine if medical device reporting and\/or corrections and removals are required.<\/p>\n<h3>Labeling Options and Their Implications<\/h3>\n<p>The manufacturer outside the USA may decide to label the product as a) &quot;Manufactured by&quot;, b) &quot;Manufactured for&quot;, or c) &quot;Distributed by.&quot; Options &quot;b&quot; and &quot;c&quot; would list the importer&#39;s name, while option &quot;a&quot; would list the manufacturer&#39;s name. This situation often occurs when US companies want to be the distributor for a product made outside the USA, and the company wants a private labeled product. This also happens when the OEM wants the option to have multiple US distributors.<\/p>\n<h3>UDI Requirements for Private Label Products<\/h3>\n<p>If you&#39;re labeling a private label medical device, you are still responsible for ensuring that the UDI is properly applied and that all GUDID submissions reflect accurate data.<\/p>\n<p>Since the distributor&#39;s name is on the product, the distributor will need to assign the &quot;DI&quot; portion of the UDI number.<\/p>\n<h3>What You Don&#39;t Need to Do<\/h3>\n<p>Private label distributors are not &quot;manufacturers&quot; subject to FDA regulation and are not required to register with FDA under 21 C.F.R. Part 807. The private label distributor does not own the 510(k), is not the specification developer, does not repackage or relabel, and does not manufacture the product.<\/p>\n<p>However, private label agreements and OEM relationships should be reviewed carefully to determine which party is responsible for listing under FDA rules.<\/p>\n<div class=\"claim-pair\">\n<div class=\"claim claim-true\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2714<\/span> All brand names, including private labels, must be identified in the FDA FURLS device listing database <span class=\"claim-label\">True<\/span><\/div>\n<div class=\"claim-explanation\">FDA requires device listings to include all proprietary names under which a device is marketed, ensuring complete traceability regardless of branding.<\/div>\n<\/div>\n<div class=\"claim claim-false\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2718<\/span> Private label distributors must submit their own 510(k) clearance for the device <span class=\"claim-label\">False<\/span><\/div>\n<div class=\"claim-explanation\">The original manufacturer or specification developer holds 510(k) clearance. Private label distributors using identical devices with only branding changes do not need separate clearances.<\/div>\n<\/div>\n<\/div>\n<h2>What specific FDA documentation must I provide to ensure my pressotherapy shipment clears US customs without delays?<\/h2>\n<p>When we ship pressotherapy equipment to US customers, documentation determines whether products clear in days or sit in customs for weeks. Getting this right requires understanding exactly what CBP and FDA verify at the point of entry.<\/p>\n<p><strong>To clear US customs without delays, provide the foreign manufacturer&#39;s FDA Registration Number, Device Listing Number, 510(k) clearance number (if applicable), correct FDA Product Code, and Affirmation of Compliance codes in your entry filing\u2014CBP transmits this data to FDA, which cross-references against internal databases before releasing shipments.<\/strong><\/p>\n<p><img decoding=\"async\" style=\"max-width:100%; height:auto;\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2026\/02\/v2-article-1771325482822-5.jpg\" alt=\"Essential FDA documentation for clearing US customs with pressotherapy machine shipments without delays (ID#5)\" title=\"FDA Customs Clearance Documentation\"><\/p>\n<h3>What FDA Verifies at Import<\/h3>\n<p>At the time of importation, the FDA will verify compliance with the following requirements as applicable. The FDA conducts field examinations and analyzes samples of medical devices to ensure they comply with applicable standards and\/or label requirements. The FDA checks the import alert database to ensure the manufacturer or product is not subject to detention without physical exam (DWPE) and listed on an import alert.<\/p>\n<p>The FDA entry reviewers are trained to verify compliance with applicable product requirements using the information provided to the FDA in the importer&#39;s entry transmission. These entry declarations are compared to information in the FDA&#39;s internal data systems. The FDA uses the internal data systems to verify registration, listing, device approval (when required) or other product requirements.<\/p>\n<h3>Required CBP\/ACE Filing Elements<\/h3>\n<p>An ACE filer must submit the following information at the time of filing entry in ACE for medical devices regulated by the FDA Center for Devices and Radiological Health. Registration and listing. For a medical device, the Registration Number for Foreign Manufacturers, Foreign Exporters, and\/or Domestic Manufacturers, and the Device Listing Number, required under section 510 of the Federal Food, Drug, and Cosmetic Act and part 807.<\/p>\n<table>\n<thead>\n<tr>\n<th>Required Data Element<\/th>\n<th>Description<\/th>\n<th>Source<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Registration Number<\/td>\n<td>Foreign manufacturer&#39;s FDA registration<\/td>\n<td>Manufacturer<\/td>\n<\/tr>\n<tr>\n<td>Device Listing Number<\/td>\n<td>Specific product listing<\/td>\n<td>Manufacturer<\/td>\n<\/tr>\n<tr>\n<td>FDA Product Code<\/td>\n<td>Alphanumeric device identifier<\/td>\n<td>FDA database<\/td>\n<\/tr>\n<tr>\n<td>510(k) Number<\/td>\n<td>Premarket clearance reference<\/td>\n<td>FDA 510(k) database<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/www.fda.gov\/industry\/import-basics\/affirmation-compliance-codes\" target=\"_blank\" rel=\"noopener noreferrer\">Affirmation of Compliance Codes<\/a> <sup id=\"ref-10\"><a href=\"#footnote-10\" class=\"footnote-ref\">10<\/a><\/sup><\/td>\n<td>Compliance descriptors<\/td>\n<td>FDA AOC list<\/td>\n<\/tr>\n<tr>\n<td>Country of Production<\/td>\n<td>Where device was manufactured<\/td>\n<td>Shipping documents<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Affirmation of Compliance (AOC) Codes<\/h3>\n<p>FDA requires importers report the Affirmation of Compliance (AOC) code for all imports of medical devices, whether or not they are finished devices. The AOC is a descriptive data element that identifies specific information FDA requires to determine clearance, release from custody and entry of an imported item. FDA provides an online list of all AOC codes to help importers determine the correct AOC to report.<\/p>\n<h3>Initial Importer Registration Requirements<\/h3>\n<p>Foreign Establishment: Prior to importing device to United States for first time. Initial Importer: Prior to importing device to United States for first time\u2014Only register; do not list device\u2014Identify manufacturer of each imported device. If not done, FDA will work with Customs and Border Patrol to detain and hold shipment.<\/p>\n<p>With the exception of Initial Importer, FDA also requires registered establishments to list the devices. An initial importer who is responsible for furthering the marketing of a device entering the US from a foreign manufacturer to the final distributor for sale of the device to the ultimate consumer or user must register their establishment, but is not required to list the devices.<\/p>\n<h3>Common Causes of Customs Delays<\/h3>\n<p>All medical device import entries undergo automated FDA review checking registration status, device listing, and compliance history. FDA uses risk-based criteria to select entries for enhanced review or physical examination.<\/p>\n<p>Avoid these common errors:<\/p>\n<ul>\n<li>Registration number mismatch with FDA database<\/li>\n<li>Missing or incorrect device listing number<\/li>\n<li>Wrong product code assignment<\/li>\n<li>Expired registration (not renewed for current fiscal year)<\/li>\n<li>Import alert on manufacturer or product<\/li>\n<\/ul>\n<h3>Working with Customs Brokers<\/h3>\n<p>Work closely with a customs broker who is experienced in medical device imports. Ensure that all customs documentation is complete and accurate.<\/p>\n<p>Most importers hire licensed customs brokers to facilitate the importation process and ensure accurate documentation and compliance. Importers remain ultimately responsible for compliance regardless of broker involvement and must provide accurate information and documentation.<\/p>\n<div class=\"claim-pair\">\n<div class=\"claim claim-true\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2714<\/span> FDA verifies registration, listing, and clearance status by comparing entry data against internal databases before releasing shipments <span class=\"claim-label\">True<\/span><\/div>\n<div class=\"claim-explanation\">FDA&#8217;s automated screening system cross-references all import entry information against CDRH databases, triggering holds when discrepancies are detected.<\/div>\n<\/div>\n<div class=\"claim claim-false\">\n<div class=\"claim-title\"><span class=\"claim-icon\">\u2718<\/span> Once you have a customs bond, no FDA-specific documentation is required for medical device imports <span class=\"claim-label\">False<\/span><\/div>\n<div class=\"claim-explanation\">Customs bonds cover duty payments but do not satisfy FDA requirements. Medical device imports require registration numbers, listing numbers, product codes, and applicable clearance information.<\/div>\n<\/div>\n<\/div>\n<h2>Conclusion<\/h2>\n<p>Understanding FDA requirements before purchasing pressotherapy machines protects your business from costly delays and compliance failures. Verify 510(k) clearance for Class II devices, confirm manufacturer registration and listing, establish clear OEM agreements, and prepare complete customs documentation.<\/p>\n<hr>\n<h2>Footnotes<\/h2>\n<p><span id=\"footnote-1\"><br \/>\n1. Official FDA information on general controls applicable to all medical devices. <a href=\"#ref-1\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-2\"><br \/>\n2. FDA&#8217;s official description of special controls for Class II medical devices. <a href=\"#ref-2\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-3\"><br \/>\n3. Official FDA page explaining the 510(k) premarket notification process for medical devices. <a href=\"#ref-3\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-4\"><br \/>\n4. FDA&#8217;s official guidance on who must register and list medical device establishments. <a href=\"#ref-4\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-5\"><br \/>\n5. Official FDA page detailing the Premarket Approval (PMA) process for Class III medical devices. <a href=\"#ref-5\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-6\"><br \/>\n6. FDA&#8217;s comprehensive guide to general labeling requirements for medical devices (21 CFR Part 801). <a href=\"#ref-6\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-7\"><br \/>\n7. FDA&#8217;s official definition and regulatory controls for Class II medical devices. <a href=\"#ref-7\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-8\"><br \/>\n8. Replaced HTTP 404 with an authoritative FDA page explaining predicate devices in the context of 510(k) submissions. <a href=\"#ref-8\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-9\"><br \/>\n9. Replaced HTTP 404 with the official FDA page detailing requirements and responsibilities of U.S. Agents for foreign establishments. <a href=\"#ref-9\" class=\"footnote-backref\">\u21a9\ufe0e<\/a><br \/>\n<\/span><\/p>\n<p><span id=\"footnote-10\"><br \/>\n10. FDA&#8217;s official explanation of Affirmation of Compliance codes for imported products. <a href=\"#ref-10\" 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 Are the US FDA Registration Requirements When Buying a Pressotherapy Machine?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"When buying a pressotherapy machine for the US market, buyers must verify the device has valid FDA 510(k) clearance if classified as Class II, confirm the foreign manufacturer's establishment registration with a designated US agent, and ensure proper device listing under 21 CFR Part 807\u2014registration alone does not guarantee device safety or efficacy.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"How do I determine if my pressotherapy machine requires FDA 510(k) clearance or just facility registration?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Pressotherapy machines typically fall under Class II medical devices, requiring FDA 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. 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folgenden\u2026<\/p>","protected":false},"author":3,"featured_media":12341,"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 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