{"id":8412,"date":"2025-11-20T23:14:59","date_gmt":"2025-11-20T23:14:59","guid":{"rendered":"https:\/\/kmslaser.com\/?p=8412"},"modified":"2025-11-20T23:14:59","modified_gmt":"2025-11-20T23:14:59","slug":"la-maquina-de-terapia-de-ondas-de-choque-requiere-certificacion-ul","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/es\/does-the-shockwave-therapy-machine-require-ul-certification\/","title":{"rendered":"\u00bfLa m\u00e1quina de terapia de ondas de choque requiere certificaci\u00f3n UL?"},"content":{"rendered":"<p style=\"float: right; margin-left: 15px; margin-bottom: 15px;\">\n  <img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/1a-technical-infographic-style-rendering-showing-th.jpg\" alt=\"Infograf\u00eda de la v\u00eda regulatoria para los pasos de cumplimiento de dispositivos m\u00e9dicos (ID#1)\" class=\"top-image-square\">\n<\/p>\n<p>Como fabricante, recibo esta pregunta en casi todas las llamadas de adquisici\u00f3n en EE. UU., as\u00ed que expondr\u00e9 la realidad pr\u00e1ctica y regulatoria en un lenguaje claro. <sup><a href=\"#footnote-1\" id=\"ref-1\">1<\/a><\/sup><\/p>\n<p><strong>La certificaci\u00f3n UL en s\u00ed misma no es un requisito legal de la FDA, pero una lista reconocida de NRTL seg\u00fan IEC\/UL 60601-1 (y 60601-1-2 para EMC) es efectivamente obligatoria para la aceptaci\u00f3n en hospitales de EE. UU., inspecciones el\u00e9ctricas, incorporaci\u00f3n de aseguradoras y muchos contratos de distribuidores.<\/strong><\/p>\n<p>Aqu\u00ed explicamos c\u00f3mo navegamos entre UL y CE, qu\u00e9 documentos debe exigir y cu\u00e1ndo una marca UL es obligatoria frente a fuertemente recomendada.<\/p>\n<hr \/>\n<h2>\u00bfQu\u00e9 certificaciones de seguridad son esenciales para ingresar al mercado estadounidense?<\/h2>\n<p>Como fabricante, dise\u00f1o para EE. UU. desde el primer d\u00eda: seguridad IEC\/UL 60601-1, EMC 60601-1-2 y una lista NRTL (UL, ETL\/Intertek, T\u00dcV, CSA). Esa combinaci\u00f3n mantiene las licitaciones en movimiento y los dispositivos fuera del purgatorio aduanero. <sup><a href=\"#footnote-2\" id=\"ref-2\">2<\/a><\/sup><\/p>\n<p><strong>Para ingresar al mercado de la salud de EE. UU., necesita: (1) v\u00eda de dispositivo de la FDA (por ejemplo, 510(k) si corresponde), (2) seguridad el\u00e9ctrica + EMC seg\u00fan IEC\/UL 60601-1\/-1-2, y (3) una lista y etiqueta de un Laboratorio de Pruebas Reconocido Nacionalmente (NRTL). Muchos hospitales requieren expl\u00edcitamente una marca UL o NRTL equivalente en la placa de identificaci\u00f3n.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/2a-detailed-illustration-of-a-proper-u-s-compliant.jpg\" alt=\"Placa de equipo con etiqueta UL que muestra las certificaciones de seguridad (ID#2)\" title=\"Etiquetado de seguridad UL\" \/><\/p>\n<h3>Lo que un comprador deber\u00eda ver en un dispositivo que cumple<\/h3>\n<ul>\n<li>Marca de lista NRTL (UL, ETL, T\u00dcV, CSA)  <\/li>\n<li>IEC\/UL 60601-1 Ed. 3.x, e IEC 60601-1-2 Ed. 4.x  <\/li>\n<li>Etiquetado para uso profesional en atenci\u00f3n m\u00e9dica \/ uso dom\u00e9stico  <\/li>\n<li>Documentaci\u00f3n de FDA 510(k) o exenci\u00f3n  <\/li>\n<li>certificaci\u00f3n ISO 13485  <\/li>\n<\/ul>\n<h3>Tabla 1 \u2014 Esenciales para la entrada a EE. UU. (a simple vista)<\/h3>\n<table>\n<thead>\n<tr>\n<th>Categor\u00eda<\/th>\n<th>Expectativa m\u00ednima<\/th>\n<th>Por qu\u00e9 es importante<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Seguran\u00e7a el\u00e9trica<\/td>\n<td>IEC\/UL 60601-1 (Ed. 3.x)<\/td>\n<td>Protecci\u00f3n del paciente\/operador<\/td>\n<\/tr>\n<tr>\n<td>EMC<\/td>\n<td>IEC 60601-1-2 (Ed. 4.x)<\/td>\n<td>Inmunidad y emisiones<\/td>\n<\/tr>\n<tr>\n<td>Listado NRTL<\/td>\n<td>UL \/ ETL \/ T\u00dcV \/ CSA<\/td>\n<td>Requerido por inspectores y hospitales<\/td>\n<\/tr>\n<tr>\n<td>V\u00eda de la FDA<\/td>\n<td>510(k)\/De Novo\/exenci\u00f3n<\/td>\n<td>Autorizaci\u00f3n legal<\/td>\n<\/tr>\n<tr>\n<td>SGQ<\/td>\n<td>ISO 13485<\/td>\n<td>Calidad de fabricaci\u00f3n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u00bfC\u00f3mo se compara UL con CE u otras normas de seguridad internacionales?<\/h2>\n<p>Como fabricante, trato a UL como una puerta de entrada norteamericana y a CE como el pasaporte de la UE. Ambos se remontan a IEC 60601, pero cada uno tiene reglas, auditor\u00edas y expectativas locales. <sup><a href=\"#footnote-3\" id=\"ref-3\">3<\/a><\/sup><\/p>\n<p><strong>UL (u otro NRTL) es la ruta de conformidad de EE. UU.\/Canad\u00e1\u2026 El marcado CE demuestra la conformidad con el MDR de la UE\u2026 El Esquema CB de IECEE puede transferir datos de prueba\u2026<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/3a-side-by-side-comparison-graphic-showing-ul-nrtl-.jpg\" alt=\"Gr\u00e1fico de comparaci\u00f3n de cumplimiento UL-NRTL y CE\/MDR (ID#3)\" title=\"Comparaci\u00f3n de cumplimiento\" \/><\/p>\n<h3>Tabla 2 \u2014 UL vs. CE vs. Esquema CB<\/h3>\n<table>\n<thead>\n<tr>\n<th>Aspecto<\/th>\n<th>UL\/NRTL<\/th>\n<th>CE<\/th>\n<th>Esquema CB<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Base legal<\/td>\n<td>OSHA\/NRTL, NFPA 99<\/td>\n<td>MDR de la UE<\/td>\n<td>Reconocimiento mutuo IEC<\/td>\n<\/tr>\n<tr>\n<td>Normas<\/td>\n<td>IEC 60601 + desviaciones US\/CA<\/td>\n<td>EN 60601<\/td>\n<td>IEC 60601<\/td>\n<\/tr>\n<tr>\n<td>Marca<\/td>\n<td>UL\/ETL\/T\u00dcV\/CSA<\/td>\n<td>CE<\/td>\n<td>Sin marca<\/td>\n<\/tr>\n<tr>\n<td>Usan<\/td>\n<td>Hospitales, inspectores AHJ<\/td>\n<td>Licitaciones de la UE<\/td>\n<td>Pasaporte de datos<\/td>\n<\/tr>\n<tr>\n<td>Qui\u00e9n lo requiere<\/td>\n<td>Aseguradoras, hospitales<\/td>\n<td>Reguladores de la UE<\/td>\n<td>Organismos de certificaci\u00f3n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>En resumen:<\/strong> CE \u2260 UL. Un dispositivo con marcado CE a\u00fan necesita una certificaci\u00f3n de un NRTL de EE. UU. para su aceptaci\u00f3n en hospitales. <sup><a href=\"#footnote-4\" id=\"ref-4\">4<\/a><\/sup><\/p>\n<hr \/>\n<h2>\u00bfQu\u00e9 documentaci\u00f3n deben proporcionar los proveedores para confirmar el cumplimiento de UL?<\/h2>\n<p>Como fabricante, agradezco las solicitudes de documentaci\u00f3n rigurosas; estas separan a los fabricantes de equipos originales (OEM) reales de los reenvasadores. <sup><a href=\"#footnote-5\" id=\"ref-5\">5<\/a><\/sup><\/p>\n<p><strong>Solicite un Certificado de Listado NRTL, un Certificado de Prueba CB, informes completos de prueba 60601-1\/-1-2 y fotos de la placa de identificaci\u00f3n oficial con la etiqueta NRTL.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/4a-hospital-procurement-office-scene-with-a-complia.jpg\" alt=\"Ingeniero revisando documentos de certificaci\u00f3n NRTL y EMC en la oficina (ID#4)\" title=\"Revisi\u00f3n de certificaci\u00f3n\" \/><\/p>\n<h3>Tabla 3 \u2014 Lista de verificaci\u00f3n de verificaci\u00f3n UL\/NRTL<\/h3>\n<table>\n<thead>\n<tr>\n<th>Documento<\/th>\n<th>Qu\u00e9 verificar<\/th>\n<th>Se\u00f1ales de alerta<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>NRTL Certificate<\/td>\n<td>Modelo, sitio, est\u00e1ndares<\/td>\n<td>Modelo diferente<\/td>\n<\/tr>\n<tr>\n<td>Placa de identificaci\u00f3n<\/td>\n<td>Marca, n\u00famero de archivo<\/td>\n<td>Arte falso<\/td>\n<\/tr>\n<tr>\n<td>Informe 60601-1<\/td>\n<td>Desviaciones aplicadas<\/td>\n<td>Secciones faltantes<\/td>\n<\/tr>\n<tr>\n<td>Informe EMC<\/td>\n<td>Configuraci\u00f3n + entorno<\/td>\n<td>Accesorios incorrectos<\/td>\n<\/tr>\n<tr>\n<td>Certificado CB<\/td>\n<td>Construcci\u00f3n coincide<\/td>\n<td>Opciones faltantes<\/td>\n<\/tr>\n<tr>\n<td>Control de cambios<\/td>\n<td>Registros de firmware\/hardware<\/td>\n<td>Cambios no listados<\/td>\n<\/tr>\n<tr>\n<td>ISO 13485<\/td>\n<td>Sitio y alcance correctos<\/td>\n<td>Caducado<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u00bfEs la certificaci\u00f3n UL obligatoria o recomendada seg\u00fan la aplicaci\u00f3n?<\/h2>\n<p>Como fabricante, segmento por entorno. En la pr\u00e1ctica, los hospitales exigen una marca NRTL; los med-spa pueden aceptar alternativas. <sup><a href=\"#footnote-6\" id=\"ref-6\">6<\/a><\/sup><\/p>\n<p><strong>Legalmente, UL no es \u201cla \u00fanica manera\u201d, pero una certificaci\u00f3n NRTL es de facto obligatoria en hospitales y muy recomendada en cualquier otro lugar.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/5a-premium-infographic-showing-five-application-are.jpg\" alt=\"Infograf\u00eda de la aplicaci\u00f3n (ID#5)\" title=\"Resumen de la aplicaci\u00f3n\" \/><\/p>\n<h3>Tabla 4 \u2014 Cu\u00e1ndo UL\/NRTL es requerido vs. opcional<\/h3>\n<table>\n<thead>\n<tr>\n<th>Aplicaci\u00f3n<\/th>\n<th>Expectativa<\/th>\n<th>Por qu\u00e9<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Hospitales<\/td>\n<td><strong>Obligatorio<\/strong><\/td>\n<td>NFPA 99, aseguradoras, AHJs<\/td>\n<\/tr>\n<tr>\n<td>Cadenas de cl\u00ednicas<\/td>\n<td><strong>Obligatorio<\/strong><\/td>\n<td>Cumplimiento de SOP<\/td>\n<\/tr>\n<tr>\n<td>Med-spa<\/td>\n<td>Fuertemente recomendado<\/td>\n<td>Responsabilidad<\/td>\n<\/tr>\n<tr>\n<td>Uso dom\u00e9stico<\/td>\n<td>Recomendado<\/td>\n<td>Las pruebas de inmunidad difieren<\/td>\n<\/tr>\n<tr>\n<td>Laboratorios de investigaci\u00f3n<\/td>\n<td>Caso por caso<\/td>\n<td>Revisi\u00f3n de EHS<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>La escalada en los EE. UU. es m\u00e1s f\u00e1cil cuando se incluye UL\/ETL\/T\u00dcV desde el principio. La certificaci\u00f3n retroactiva es costosa. <sup><a href=\"#footnote-7\" id=\"ref-7\">7<\/a><\/sup><\/p>\n<hr \/>\n<h2>Conclusi\u00f3n<\/h2>\n<p>Como fabricante, mi consejo es simple: construya seg\u00fan IEC 60601-1\/-1-2, planifique una lista NRTL desde el principio y mantenga los certificados y la construcci\u00f3n completamente alineados. Eso evita fallos en las inspecciones y garantiza la aceptaci\u00f3n del dispositivo en hospitales y distribuidores. <sup><a href=\"#footnote-8\" id=\"ref-8\">8<\/a><\/sup><\/p>\n<hr \/>\n<h1>Notas a pie de p\u00e1gina (Total: <strong>10<\/strong>)<\/h1>\n<p><span id=\"footnote-1\">1. OSHA explica qu\u00e9 es la certificaci\u00f3n NRTL y por qu\u00e9 es necesaria para equipos el\u00e9ctricos. <a href=\"#ref-1\">\u21a9\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.osha.gov\/nationally-recognized-testing-laboratory-program\">https:\/\/www.osha.gov\/nationally-recognized-testing-laboratory-program<\/a><\/span><br \/>\n<span id=\"footnote-2\">2. Gu\u00eda de la FDA sobre las expectativas de seguridad el\u00e9ctrica de los dispositivos m\u00e9dicos. <a href=\"#ref-2\">\u21a9\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.fda.gov\/medical-devices\">https:\/\/www.fda.gov\/medical-devices<\/a><\/span><br \/>\n<span id=\"footnote-3\">3. Resumen de IECEE del esquema CB 60601 para dispositivos m\u00e9dicos el\u00e9ctricos. <a href=\"#ref-3\">\u21a9\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.iecee.org\">https:\/\/www.iecee.org<\/a><\/span><br \/>\n<span id=\"footnote-4\">4. Resumen de UL sobre las diferencias entre el cumplimiento UL\/NRTL y CE\/IEC. <a href=\"#ref-4\">\u21a9\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.ul.com\">https:\/\/www.ul.com<\/a><\/span><br \/>\n<span id=\"footnote-5\">5. Explicaci\u00f3n de Intertek sobre la documentaci\u00f3n de la lista 60601-1 y NRTL. <a href=\"#ref-5\">\u21a9\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.intertek.com\/medical\/iec-60601\/\">https:\/\/www.intertek.com\/medical\/iec-60601\/<\/a><\/span><br \/>\n<span id=\"footnote-6\">6. Resumen de T\u00dcV S\u00dcD sobre la importancia de NRTL para el acceso al mercado de EE. UU. <a href=\"#ref-6\">\u21a9\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.tuvsud.com\/en-us\/services\/product-certification\/nrtl\">https:\/\/www.tuvsud.com\/en-us\/services\/product-certification\/nrtl<\/a><\/span><br \/>\n<span id=\"footnote-7\">7. CSA Group sobre por qu\u00e9 la lista NRTL afecta la adquisici\u00f3n de hospitales y las inspecciones de AHJ. <a href=\"#ref-7\">\u21a9\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.csagroup.org\">https:\/\/www.csagroup.org<\/a><\/span><br \/>\n<span id=\"footnote-8\">8. NFPA 99 describe las expectativas de equipos el\u00e9ctricos en instalaciones de atenci\u00f3n m\u00e9dica. <a href=\"#ref-8\">\u21a9\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.nfpa.org\/codes-and-standards\/all-codes-and-standards\/list-of-codes-and-standards\/detail?code=99\">https:\/\/www.nfpa.org\/codes-and-standards\/all-codes-and-standards\/list-of-codes-and-standards\/detail?code=99<\/a><\/span><br \/>\n<span id=\"footnote-9\">9. Resumen de ISO 13485 para el cumplimiento del SGC de dispositivos m\u00e9dicos. <a href=\"#ref-9\">\u21a9\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.iso.org\/standard\/59752.html\">https:\/\/www.iso.org\/standard\/59752.html<\/a><\/span><br \/>\n<span id=\"footnote-10\">10. Listado oficial de requisitos de EMC de la IEC 60601-1-2. <a href=\"#ref-10\">\u21a9\ufe0e<\/a> \u2014 <a href=\"https:\/\/webstore.iec.ch\/publication\/2612\">https:\/\/webstore.iec.ch\/publication\/2612<\/a><\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>As the manufacturer, I get this question in almost every U.S. procurement call, so I\u2019ll lay out the practical and regulatory reality in plain English. 1 UL certification itself is not a statutory FDA requirement, but a recognized NRTL listing to IEC\/UL 60601-1 (and 60601-1-2 for EMC) is effectively mandatory for U.S. hospital acceptance, electrical [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":8416,"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-8412","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 v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Does the Shockwave Therapy Machine require UL 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\/la-maquina-de-terapia-de-ondas-de-choque-requiere-certificacion-ul\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Does the Shockwave Therapy Machine require UL certification?\" \/>\n<meta property=\"og:description\" content=\"As the manufacturer, I get this question in almost every U.S. procurement call, so I\u2019ll lay out the practical and regulatory reality in plain English. 1 UL certification itself is not a statutory FDA requirement, but a recognized NRTL listing to IEC\/UL 60601-1 (and 60601-1-2 for EMC) is effectively mandatory for U.S. hospital acceptance, electrical [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/kmslaser.com\/es\/la-maquina-de-terapia-de-ondas-de-choque-requiere-certificacion-ul\/\" \/>\n<meta property=\"og:site_name\" content=\"KMSLaser\" \/>\n<meta property=\"article:published_time\" content=\"2025-11-20T23:14:59+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/3a-side-by-side-comparison-graphic-showing-ul-nrtl-.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"600\" \/>\n\t<meta property=\"og:image:height\" content=\"400\" \/>\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=\"1 minuto\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"\u00bfLa m\u00e1quina de terapia de ondas de choque requiere certificaci\u00f3n UL? - 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\/la-maquina-de-terapia-de-ondas-de-choque-requiere-certificacion-ul\/","og_locale":"es_MX","og_type":"article","og_title":"Does the Shockwave Therapy Machine require UL certification?","og_description":"As the manufacturer, I get this question in almost every U.S. procurement call, so I\u2019ll lay out the practical and regulatory reality in plain English. 1 UL certification itself is not a statutory FDA requirement, but a recognized NRTL listing to IEC\/UL 60601-1 (and 60601-1-2 for EMC) is effectively mandatory for U.S. hospital acceptance, electrical [&hellip;]","og_url":"https:\/\/kmslaser.com\/es\/la-maquina-de-terapia-de-ondas-de-choque-requiere-certificacion-ul\/","og_site_name":"KMSLaser","article_published_time":"2025-11-20T23:14:59+00:00","og_image":[{"width":600,"height":400,"url":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/3a-side-by-side-comparison-graphic-showing-ul-nrtl-.jpg","type":"image\/jpeg"}],"author":"Sophia Wu","twitter_card":"summary_large_image","twitter_misc":{"Escrito por":"Sophia Wu","Tiempo de lectura":"1 minuto"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/kmslaser.com\/does-the-shockwave-therapy-machine-require-ul-certification\/#article","isPartOf":{"@id":"https:\/\/kmslaser.com\/does-the-shockwave-therapy-machine-require-ul-certification\/"},"author":{"name":"Sophia Wu","@id":"https:\/\/kmslaser.com\/#\/schema\/person\/c37fe1d989e6bd9dbe4f1f7b6cfa9588"},"headline":"Does the Shockwave Therapy Machine require UL certification?","datePublished":"2025-11-20T23:14:59+00:00","mainEntityOfPage":{"@id":"https:\/\/kmslaser.com\/does-the-shockwave-therapy-machine-require-ul-certification\/"},"wordCount":829,"commentCount":0,"publisher":{"@id":"https:\/\/kmslaser.com\/#organization"},"image":{"@id":"https:\/\/kmslaser.com\/does-the-shockwave-therapy-machine-require-ul-certification\/#primaryimage"},"thumbnailUrl":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/3a-side-by-side-comparison-graphic-showing-ul-nrtl-.jpg","articleSection":["Shockwave Therapy Machine"],"inLanguage":"es","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/kmslaser.com\/does-the-shockwave-therapy-machine-require-ul-certification\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/kmslaser.com\/does-the-shockwave-therapy-machine-require-ul-certification\/","url":"https:\/\/kmslaser.com\/does-the-shockwave-therapy-machine-require-ul-certification\/","name":"\u00bfLa m\u00e1quina de terapia de ondas de choque requiere certificaci\u00f3n UL? - KMSLaser","isPartOf":{"@id":"https:\/\/kmslaser.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/kmslaser.com\/does-the-shockwave-therapy-machine-require-ul-certification\/#primaryimage"},"image":{"@id":"https:\/\/kmslaser.com\/does-the-shockwave-therapy-machine-require-ul-certification\/#primaryimage"},"thumbnailUrl":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/3a-side-by-side-comparison-graphic-showing-ul-nrtl-.jpg","datePublished":"2025-11-20T23:14:59+00:00","breadcrumb":{"@id":"https:\/\/kmslaser.com\/does-the-shockwave-therapy-machine-require-ul-certification\/#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/kmslaser.com\/does-the-shockwave-therapy-machine-require-ul-certification\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/kmslaser.com\/does-the-shockwave-therapy-machine-require-ul-certification\/#primaryimage","url":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/3a-side-by-side-comparison-graphic-showing-ul-nrtl-.jpg","contentUrl":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/3a-side-by-side-comparison-graphic-showing-ul-nrtl-.jpg","width":600,"height":400},{"@type":"BreadcrumbList","@id":"https:\/\/kmslaser.com\/does-the-shockwave-therapy-machine-require-ul-certification\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/kmslaser.com\/"},{"@type":"ListItem","position":2,"name":"Does the Shockwave Therapy Machine require UL certification?"}]},{"@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\/8412","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=8412"}],"version-history":[{"count":0,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/posts\/8412\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/media\/8416"}],"wp:attachment":[{"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/media?parent=8412"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/categories?post=8412"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/tags?post=8412"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}