{"id":8170,"date":"2025-10-11T11:19:42","date_gmt":"2025-10-11T11:19:42","guid":{"rendered":"https:\/\/kmslaser.com\/?p=8170"},"modified":"2025-10-19T13:05:24","modified_gmt":"2025-10-19T13:05:24","slug":"deben-las-maquinas-de-terapia-de-ondas-de-choque-importadas-cumplir-con-los-requisitos-o-la-certificacion-de-la-fda","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/es\/should-imported-shockwave-therapy-machines-meet-fda-requirements-or-certification\/","title":{"rendered":"\u00bfDeben las m\u00e1quinas importadas de terapia de ondas de choque cumplir con los requisitos o la certificaci\u00f3n de la FDA?"},"content":{"rendered":"<p><iframe data-testid=\"embed-iframe\" style=\"border-radius:12px\" src=\"https:\/\/open.spotify.com\/embed\/episode\/2PWlWN8VuBPgYV2y7pJsJp?utm_source=generator&amp;theme=0\" width=\"100%\" height=\"152\" frameborder=\"0\" allowfullscreen=\"\" allow=\"autoplay; clipboard-write; encrypted-media; fullscreen; picture-in-picture\" loading=\"lazy\"><\/iframe><\/p>\n<p style=\"float: right; margin-left: 15px; margin-bottom: 15px;\">\n  <img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/1close-up-product-photo-of-a-shockwave-machine-labe.jpg\" alt=\"Pieza de acero inoxidable etiquetada con CE, ISO, FDA 510k (ID#1)\" class=\"top-image-square\">\n<\/p>\n<p>Como fabricante que exporta m\u00e1quinas de terapia de ondas de choque de grado m\u00e9dico, a menudo ayudo a los compradores estadounidenses a confirmar si la autorizaci\u00f3n de la FDA es obligatoria. Muchos importadores asumen que una marca CE o una certificaci\u00f3n ISO son suficientes, pero en los EE. UU., ese no es el caso.<\/p>\n<p><strong>S\u00ed, las m\u00e1quinas de terapia de ondas de choque importadas deben cumplir con los requisitos de la FDA antes de que puedan comercializarse, distribuirse o usarse cl\u00ednicamente en los Estados Unidos. La mayor\u00eda de los modelos requieren una autorizaci\u00f3n 510(k) o una autorizaci\u00f3n De Novo, dependiendo de la clasificaci\u00f3n y el uso previsto.<\/strong><\/p>\n<p>El incumplimiento puede dar lugar a la detenci\u00f3n en aduanas, la denegaci\u00f3n de entrada o la incautaci\u00f3n del producto.<\/p>\n<hr \/>\n<h2>\u00bfEs obligatoria la autorizaci\u00f3n de la FDA para la importaci\u00f3n?<\/h2>\n<p>Muchos importadores se sorprenden de que el cumplimiento de la FDA se aplique incluso antes de que el dispositivo ingrese al mercado de EE. UU., no despu\u00e9s.<\/p>\n<p><strong>S\u00ed, la autorizaci\u00f3n de la FDA es obligatoria si el dispositivo se va a vender, distribuir o utilizar con fines terap\u00e9uticos en los EE. UU. Solo unos pocos modelos de bajo riesgo (por ejemplo, dispositivos de masaje general) est\u00e1n exentos.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/2a-u-s-customs-inspection-area-where-officers-revi.jpg\" alt=\"Oficiales de aduanas inspeccionando env\u00edo de dispositivo m\u00e9dico en almac\u00e9n (ID#2)\" title=\"Inspecci\u00f3n aduanera\" \/><\/p>\n<p>Para conocer las v\u00edas de autorizaci\u00f3n y las clases de riesgo, consulte el <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/classify-your-medical-device\">Sistema de clasificaci\u00f3n de dispositivos de la FDA<\/a><\/strong> <sup><a href=\"#footnote-1\" id=\"ref-1\">1<\/a><\/sup>.<br \/>\nLos importadores tambi\u00e9n deben revisar <strong><a href=\"https:\/\/www.fda.gov\/industry\/import-basics\/medical-devices\">Fundamentos de importaci\u00f3n de la FDA para dispositivos m\u00e9dicos<\/a><\/strong> <sup><a href=\"#footnote-2\" id=\"ref-2\">2<\/a><\/sup> para comprender la documentaci\u00f3n y el control aduanero.<\/p>\n<h3>Resumen de clasificaciones de la FDA<\/h3>\n<table>\n<thead>\n<tr>\n<th>Uso previsto \/ Tipo de modelo<\/th>\n<th>Clase de la FDA<\/th>\n<th>Tipo de autorizaci\u00f3n<\/th>\n<th>Ejemplo de c\u00f3digo de producto<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Terapia musculoesquel\u00e9tica (por ejemplo, tendinopat\u00eda, alivio del dolor)<\/td>\n<td>Clase II<\/td>\n<td>510(k)<\/td>\n<td><strong>NPV<\/strong>, <strong>ISA<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Terapia de heridas cr\u00f3nicas<\/td>\n<td>Clase II<\/td>\n<td>510(k)<\/td>\n<td><strong>PZL<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Litotricia (fragmentaci\u00f3n de c\u00e1lculos renales)<\/td>\n<td>Clase III<\/td>\n<td>PMA<\/td>\n<td><strong>78F<\/strong>, <strong>LITH<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Vibraci\u00f3n o masaje de baja energ\u00eda (afirmaciones no m\u00e9dicas)<\/td>\n<td>Clase I<\/td>\n<td>Exento (uso general)<\/td>\n<td><strong>890.5660<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Qu\u00e9 sucede sin la autorizaci\u00f3n de la FDA<\/h3>\n<p>Si un dispositivo importado llega sin un 510(k) v\u00e1lido o una exenci\u00f3n, la Aduana de EE. UU. y la FDA pueden:<\/p>\n<ul>\n<li><strong>Detener el env\u00edo<\/strong> en el puerto (ver <a href=\"https:\/\/www.accessdata.fda.gov\/cms_ia\/default.cfm\">Alertas de Importaci\u00f3n<\/a>) <sup><a href=\"#footnote-3\" id=\"ref-3\">3<\/a><\/sup>.  <\/li>\n<li><strong>Rechazar la entrada o destruir<\/strong> el dispositivo.  <\/li>\n<li><strong>Incluir en la lista negra al fabricante o importador<\/strong> para futuras importaciones.<\/li>\n<\/ul>\n<p>Incluso las unidades de demostraci\u00f3n o los env\u00edos de muestras deben incluir documentaci\u00f3n que especifique el uso no cl\u00ednico (por ejemplo, \u201csolo para exhibici\u00f3n\u201d).<\/p>\n<hr \/>\n<h2>C\u00f3mo verificar el cumplimiento de la FDA<\/h2>\n<p>Los compradores siempre deben confirmar si el modelo de un proveedor est\u00e1 autorizado por la FDA antes de la compra. Esto se puede verificar p\u00fablicamente.<\/p>\n<p><strong>Puede verificar la autorizaci\u00f3n de la FDA consultando la base de datos oficial de <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm\">base de datos FDA 510(k)<\/a><\/strong> <sup><a href=\"#footnote-4\" id=\"ref-4\">4<\/a><\/sup><br \/>\no la base de datos de <strong><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfRL\/rl.cfm\">Registro de Establecimientos y Listado de Dispositivos<\/a><\/strong> <sup><a href=\"#footnote-5\" id=\"ref-5\">5<\/a><\/sup>.<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/3a-professional-compliance-officer-reviews-fda-510-.jpg\" alt=\"Oficial regulador revisando documentos de solicitud de la FDA (ID#3)\" title=\"Proceso de revisi\u00f3n de la FDA\" \/><\/p>\n<p>Si el modelo no tiene un precedente, puede requerir <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/selecting-de-novo-direct-class-ii-route-de-novo-classification\">clasificaci\u00f3n De Novo<\/a><\/strong> <sup><a href=\"#footnote-6\" id=\"ref-6\">6<\/a><\/sup> en lugar de un 510(k) est\u00e1ndar.<\/p>\n<h3>Lista de verificaci\u00f3n de verificaci\u00f3n<\/h3>\n<table>\n<thead>\n<tr>\n<th>Paso<\/th>\n<th>Qu\u00e9 verificar<\/th>\n<th>Ejemplo de Entrada<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>1<\/td>\n<td>N\u00famero de registro de la FDA del fabricante<\/td>\n<td>por ejemplo, 3012345678<\/td>\n<\/tr>\n<tr>\n<td>2<\/td>\n<td>Listado del dispositivo con el c\u00f3digo de producto correcto<\/td>\n<td>\u201cPZL \u2013 Dispositivo, onda de choque, para la curaci\u00f3n de heridas\u201d<\/td>\n<\/tr>\n<tr>\n<td>3<\/td>\n<td>N\u00famero de 510(k) y fecha de decisi\u00f3n<\/td>\n<td>por ejemplo, <strong>K202112<\/strong> (aprobado 2021)<\/td>\n<\/tr>\n<tr>\n<td>4<\/td>\n<td>Agente o importador de EE. UU. listado<\/td>\n<td>Registrado bajo el mismo nombre de fabricante<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Se\u00f1ales de Alerta<\/h3>\n<ul>\n<li>El proveedor solo proporciona un \u201ccertificado CE\u201d.\u201d  <\/li>\n<li>El n\u00famero de la FDA no coincide con el nombre de la empresa.  <\/li>\n<li>Afirma \u201cFDA registrada\u201d sin prueba de aprobaci\u00f3n.<\/li>\n<\/ul>\n<p>Registro \u2260 aprobaci\u00f3n. Solo una carta oficial de 510(k) confirma la autorizaci\u00f3n de comercializaci\u00f3n en EE. UU.<\/p>\n<hr \/>\n<h2>\u00bfQu\u00e9 documentos prueban la aprobaci\u00f3n de la FDA?<\/h2>\n<p>En mi experiencia, los compradores deben solicitar la siguiente documentaci\u00f3n para verificar el cumplimiento antes del env\u00edo.<\/p>\n<p><strong>Los documentos que prueban el cumplimiento de la FDA incluyen la carta de aprobaci\u00f3n de 510(k), el registro del listado del dispositivo, el certificado de registro del establecimiento y el etiquetado que coincide con la indicaci\u00f3n aprobada.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/4close-up-of-an-official-fda-510-k-clearance-lette.jpg\" alt=\"Documento de autorizaci\u00f3n FDA 510(k) firmado sobre el escritorio (ID#4)\" title=\"Aprobaci\u00f3n 510k\" \/><\/p>\n<p>Los compradores de EE. UU. tambi\u00e9n deben garantizar el cumplimiento de <strong><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-820\">21 CFR Parte 820 Regulaci\u00f3n del Sistema de Calidad<\/a><\/strong> <sup><a href=\"#footnote-7\" id=\"ref-7\">7<\/a><\/sup> and<br \/>\n<strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/labeling-requirements\">Requisitos de etiquetado de la FDA para dispositivos<\/a><\/strong> <sup><a href=\"#footnote-8\" id=\"ref-8\">8<\/a><\/sup>.<\/p>\n<h3>Lista esencial de documentaci\u00f3n de la FDA<\/h3>\n<table>\n<thead>\n<tr>\n<th>Nombre del Documento<\/th>\n<th>Prop\u00f3sito \/ Uso de Verificaci\u00f3n<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>Carta de autorizaci\u00f3n 510(k) de la FDA<\/strong><\/td>\n<td>Confirmaci\u00f3n oficial de autorizaci\u00f3n de mercado.<\/td>\n<\/tr>\n<tr>\n<td><strong>Registro de listado de dispositivos<\/strong><\/td>\n<td>Muestra el nombre del producto, la clase y el registro del fabricante.<\/td>\n<\/tr>\n<tr>\n<td><strong>Registro del Establecimiento<\/strong><\/td>\n<td>Confirma que la f\u00e1brica extranjera y el agente de EE. UU. est\u00e1n registrados.<\/td>\n<\/tr>\n<tr>\n<td><strong>Hoja de etiquetado e indicaciones<\/strong><\/td>\n<td>Debe coincidir con el uso previsto autorizado por la FDA.<\/td>\n<\/tr>\n<tr>\n<td><strong>Certificado del Sistema de Calidad (21 CFR 820)<\/strong><\/td>\n<td>Demuestra el cumplimiento de los est\u00e1ndares de fabricaci\u00f3n.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Malentendidos comunes<\/h3>\n<ul>\n<li>Una empresa puede estar \u201cregistrada en la FDA\u201d sin su <strong>dispositivo<\/strong> siendo despejado.  <\/li>\n<li>CE o ISO 13485 son <strong>no sustitutos<\/strong> para la aprobaci\u00f3n de la FDA.  <\/li>\n<li>Cada modelo requiere su propio n\u00famero 510(k).<\/li>\n<\/ul>\n<p>M\u00e1s informaci\u00f3n sobre los roles del importador se puede encontrar en <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/establishment-registration-medical-devices\">la gu\u00eda de registro de establecimientos de la FDA<\/a><\/strong> <sup><a href=\"#footnote-9\" id=\"ref-9\">9<\/a><\/sup>.<\/p>\n<hr \/>\n<h2>\u00bfSe aplican las reglas de la FDA a todos los modelos?<\/h2>\n<p>No todos los sistemas de ondas de choque se regulan de la misma manera. La clasificaci\u00f3n depende del <strong>uso m\u00e9dico previsto<\/strong>, <strong>nivel de energ\u00eda<\/strong>, y <strong>afirmaciones de marketing<\/strong>.<\/p>\n<p><strong>S\u00ed, todos los modelos vendidos o utilizados para fines m\u00e9dicos en los EE. UU. est\u00e1n sujetos a las reglas de la FDA, pero los modelos de \u201cmasaje\u201d de baja energ\u00eda pueden estar exentos si no se hacen afirmaciones m\u00e9dicas.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/5illustration-showing-four-types-of-shockwave-machi.jpg\" alt=\"L\u00ednea de m\u00e1quinas de ondas de choque m\u00e9dicas con prop\u00f3sitos etiquetados (ID#5)\" title=\"L\u00ednea de productos Shockwave\" \/><\/p>\n<p>Para ver las listas de exenciones, consulte el <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/510k-exempt-devices\">Directorio de Dispositivos Exentos de 510(k) de la FDA<\/a><\/strong> <sup><a href=\"#footnote-10\" id=\"ref-10\">10<\/a><\/sup>.<\/p>\n<hr \/>\n<h2>Conclusi\u00f3n<\/h2>\n<p>Cualquier m\u00e1quina de terapia de ondas de choque importada a los EE. UU. para uso cl\u00ednico debe cumplir con las regulaciones de la FDA, generalmente a trav\u00e9s de una aprobaci\u00f3n 510(k) o PMA. Siempre verifique la aprobaci\u00f3n en la base de datos de la FDA, solicite documentos oficiales a su proveedor y aseg\u00farese de que el etiquetado y la comercializaci\u00f3n coincidan con las indicaciones aprobadas.<br \/>\n<strong>El cumplimiento no es opcional: es la base de la importaci\u00f3n legal y la operaci\u00f3n segura en el mercado de EE. UU.<\/strong><\/p>\n<hr \/>\n<h2>Notas al pie<\/h2>\n<p><span id=\"footnote-1\">1. Resumen de la clasificaci\u00f3n de dispositivos m\u00e9dicos de la FDA. <a href=\"#ref-1\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-2\">2. Gu\u00eda de importaci\u00f3n de la FDA para env\u00edos de dispositivos m\u00e9dicos. <a href=\"#ref-2\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-3\">3. Alertas de importaci\u00f3n de la FDA para productos no conformes. <a href=\"#ref-3\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-4\">4. Base de datos de b\u00fasqueda de autorizaci\u00f3n 510(k) de la FDA. <a href=\"#ref-4\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-5\">5. Base de datos de listado y registro de dispositivos de la FDA. <a href=\"#ref-5\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-6\">6. V\u00eda de clasificaci\u00f3n De Novo para nuevos dispositivos. <a href=\"#ref-6\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-7\">7. Regulaci\u00f3n del Sistema de Calidad (21 CFR Parte 820). <a href=\"#ref-7\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-8\">8. Reglas de etiquetado e indicaciones de la FDA para dispositivos. <a href=\"#ref-8\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-9\">9. Requisitos de registro y agente de EE. UU. <a href=\"#ref-9\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-10\">10. Lista de dispositivos exentos de 510(k) de la FDA. <a href=\"#ref-10\">\u21a9\ufe0e<\/a><\/span>  <\/p>","protected":false},"excerpt":{"rendered":"<p>As a manufacturer that exports medical-grade shockwave therapy machines, I often help U.S. buyers confirm whether FDA clearance is mandatory. Many importers assume that a CE mark or ISO certification is enough\u2014but in the U.S., that\u2019s not the case. Yes, imported shockwave therapy machines must meet FDA requirements before they can be marketed, distributed, or [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":8174,"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":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","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":[60],"tags":[],"class_list":["post-8170","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-shockwave-therapy-machine"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Should Imported Shockwave Therapy Machines Meet FDA Requirements or Certification? - 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\/deben-las-maquinas-de-terapia-de-ondas-de-choque-importadas-cumplir-con-los-requisitos-o-la-certificacion-de-la-fda\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Should Imported Shockwave Therapy Machines Meet FDA Requirements or Certification?\" \/>\n<meta property=\"og:description\" content=\"As a manufacturer that exports medical-grade shockwave therapy machines, I often help U.S. buyers confirm whether FDA clearance is mandatory. Many importers assume that a CE mark or ISO certification is enough\u2014but in the U.S., that\u2019s not the case. Yes, imported shockwave therapy machines must meet FDA requirements before they can be marketed, distributed, or [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/kmslaser.com\/es\/deben-las-maquinas-de-terapia-de-ondas-de-choque-importadas-cumplir-con-los-requisitos-o-la-certificacion-de-la-fda\/\" \/>\n<meta property=\"og:site_name\" content=\"KMSLaser\" \/>\n<meta property=\"article:published_time\" content=\"2025-10-11T11:19:42+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-10-19T13:05:24+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/3a-professional-compliance-officer-reviews-fda-510-.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"679\" \/>\n\t<meta property=\"og:image:height\" content=\"453\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\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=\"5 minutos\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"\u00bfDeben las m\u00e1quinas de terapia de ondas de choque importadas cumplir con los requisitos o certificaciones de la FDA? - 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\/deben-las-maquinas-de-terapia-de-ondas-de-choque-importadas-cumplir-con-los-requisitos-o-la-certificacion-de-la-fda\/","og_locale":"es_MX","og_type":"article","og_title":"Should Imported Shockwave Therapy Machines Meet FDA Requirements or Certification?","og_description":"As a manufacturer that exports medical-grade shockwave therapy machines, I often help U.S. buyers confirm whether FDA clearance is mandatory. Many importers assume that a CE mark or ISO certification is enough\u2014but in the U.S., that\u2019s not the case. Yes, imported shockwave therapy machines must meet FDA requirements before they can be marketed, distributed, or [&hellip;]","og_url":"https:\/\/kmslaser.com\/es\/deben-las-maquinas-de-terapia-de-ondas-de-choque-importadas-cumplir-con-los-requisitos-o-la-certificacion-de-la-fda\/","og_site_name":"KMSLaser","article_published_time":"2025-10-11T11:19:42+00:00","article_modified_time":"2025-10-19T13:05:24+00:00","og_image":[{"width":679,"height":453,"url":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/3a-professional-compliance-officer-reviews-fda-510-.jpg","type":"image\/jpeg"}],"author":"Sophia Wu","twitter_card":"summary_large_image","twitter_misc":{"Escrito por":"Sophia Wu","Tiempo de lectura":"5 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/kmslaser.com\/should-imported-shockwave-therapy-machines-meet-fda-requirements-or-certification\/#article","isPartOf":{"@id":"https:\/\/kmslaser.com\/should-imported-shockwave-therapy-machines-meet-fda-requirements-or-certification\/"},"author":{"name":"Sophia Wu","@id":"https:\/\/kmslaser.com\/#\/schema\/person\/c37fe1d989e6bd9dbe4f1f7b6cfa9588"},"headline":"Should Imported Shockwave Therapy Machines Meet FDA Requirements or Certification?","datePublished":"2025-10-11T11:19:42+00:00","dateModified":"2025-10-19T13:05:24+00:00","mainEntityOfPage":{"@id":"https:\/\/kmslaser.com\/should-imported-shockwave-therapy-machines-meet-fda-requirements-or-certification\/"},"wordCount":805,"commentCount":0,"publisher":{"@id":"https:\/\/kmslaser.com\/#organization"},"image":{"@id":"https:\/\/kmslaser.com\/should-imported-shockwave-therapy-machines-meet-fda-requirements-or-certification\/#primaryimage"},"thumbnailUrl":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/3a-professional-compliance-officer-reviews-fda-510-.jpg","articleSection":["Shockwave Therapy Machine"],"inLanguage":"es","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/kmslaser.com\/should-imported-shockwave-therapy-machines-meet-fda-requirements-or-certification\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/kmslaser.com\/should-imported-shockwave-therapy-machines-meet-fda-requirements-or-certification\/","url":"https:\/\/kmslaser.com\/should-imported-shockwave-therapy-machines-meet-fda-requirements-or-certification\/","name":"\u00bfDeben las m\u00e1quinas de terapia de ondas de choque importadas cumplir con los requisitos o certificaciones de la FDA? 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