{"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":"%d9%87%d9%84-%d9%8a%d8%ac%d8%a8-%d8%a3%d9%86-%d8%aa%d9%84%d8%a8%d9%8a-%d8%a3%d8%ac%d9%87%d8%b2%d8%a9-%d8%a7%d9%84%d8%b9%d9%84%d8%a7%d8%ac-%d8%a8%d8%a7%d9%84%d8%b5%d8%af%d9%85%d8%a7%d8%aa-%d8%a7%d9%84","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/ar\/should-imported-shockwave-therapy-machines-meet-fda-requirements-or-certification\/","title":{"rendered":"\u0647\u0644 \u064a\u062c\u0628 \u0623\u0646 \u062a\u0641\u064a \u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f\u0629 \u0628\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 \u0623\u0648 \u0634\u0647\u0627\u062f\u0627\u062a\u0647\u0627\u061f"},"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=\"\u062c\u0632\u0621 \u0645\u0646 \u0627\u0644\u0641\u0648\u0644\u0627\u0630 \u0627\u0644\u0645\u0642\u0627\u0648\u0645 \u0644\u0644\u0635\u062f\u0623 \u064a\u062d\u0645\u0644 \u0639\u0644\u0627\u0645\u0629 CE\u060c ISO\u060c FDA 510k (ID#1)\" class=\"top-image-square\">\n<\/p>\n<p>\u0628\u0635\u0641\u062a\u064a \u0645\u064f\u0635\u0646\u0650\u0651\u0639\u064b\u0627 \u064a\u0635\u062f\u0631 \u0622\u0644\u0627\u062a \u0639\u0644\u0627\u062c \u0627\u0644\u0635\u062f\u0645\u0627\u062a \u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\u060c \u063a\u0627\u0644\u0628\u064b\u0627 \u0645\u0627 \u0623\u0633\u0627\u0639\u062f \u0627\u0644\u0645\u0634\u062a\u0631\u064a\u0646 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u064a\u0646 \u0641\u064a \u062a\u0623\u0643\u064a\u062f \u0645\u0627 \u0625\u0630\u0627 \u0643\u0627\u0646 \u062a\u0635\u0631\u064a\u062d \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 \u0625\u0644\u0632\u0627\u0645\u064a\u064b\u0627. \u064a\u0641\u062a\u0631\u0636 \u0627\u0644\u0639\u062f\u064a\u062f \u0645\u0646 \u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f\u064a\u0646 \u0623\u0646 \u0639\u0644\u0627\u0645\u0629 CE \u0623\u0648 \u0634\u0647\u0627\u062f\u0629 ISO \u0643\u0627\u0641\u064a\u0629 - \u0648\u0644\u0643\u0646 \u0641\u064a \u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629\u060c \u0647\u0630\u0627 \u0644\u064a\u0633 \u0647\u0648 \u0627\u0644\u062d\u0627\u0644.<\/p>\n<p><strong>\u0646\u0639\u0645\u060c \u064a\u062c\u0628 \u0623\u0646 \u062a\u0644\u0628\u064a \u0622\u0644\u0627\u062a \u0627\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0635\u062f\u0645\u0627\u062a \u0627\u0644\u0643\u0647\u0631\u0628\u0627\u0626\u064a\u0629 \u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f\u0629 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 \u0642\u0628\u0644 \u0623\u0646 \u064a\u062a\u0645 \u062a\u0633\u0648\u064a\u0642\u0647\u0627 \u0623\u0648 \u062a\u0648\u0632\u064a\u0639\u0647\u0627 \u0623\u0648 \u0627\u0633\u062a\u062e\u062f\u0627\u0645\u0647\u0627 \u0633\u0631\u064a\u0631\u064a\u064b\u0627 \u0641\u064a \u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629. \u062a\u062a\u0637\u0644\u0628 \u0645\u0639\u0638\u0645 \u0627\u0644\u0645\u0648\u062f\u064a\u0644\u0627\u062a \u0625\u0645\u0627 \u062a\u0635\u0631\u064a\u062d 510 (k) \u0623\u0648 \u062a\u0631\u062e\u064a\u0635 De Novo \u0627\u0639\u062a\u0645\u0627\u062f\u064b\u0627 \u0639\u0644\u0649 \u0627\u0644\u062a\u0635\u0646\u064a\u0641 \u0648\u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0645\u0642\u0635\u0648\u062f.<\/strong><\/p>\n<p>\u0642\u062f \u064a\u0624\u062f\u064a \u0639\u062f\u0645 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0625\u0644\u0649 \u0627\u062d\u062a\u062c\u0627\u0632 \u0627\u0644\u062c\u0645\u0627\u0631\u0643 \u0623\u0648 \u0631\u0641\u0636 \u0627\u0644\u062f\u062e\u0648\u0644 \u0623\u0648 \u0645\u0635\u0627\u062f\u0631\u0629 \u0627\u0644\u0645\u0646\u062a\u062c.<\/p>\n<hr \/>\n<h2>\u0647\u0644 \u062a\u0635\u0631\u064a\u062d \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 \u0625\u0644\u0632\u0627\u0645\u064a \u0644\u0644\u0627\u0633\u062a\u064a\u0631\u0627\u062f\u061f<\/h2>\n<p>\u064a\u062a\u0641\u0627\u062c\u0623 \u0627\u0644\u0639\u062f\u064a\u062f \u0645\u0646 \u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f\u064a\u0646 \u0628\u0623\u0646 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 \u064a\u0646\u0637\u0628\u0642 \u062d\u062a\u0649 \u0642\u0628\u0644 \u062f\u062e\u0648\u0644 \u0627\u0644\u062c\u0647\u0627\u0632 \u0625\u0644\u0649 \u0627\u0644\u0633\u0648\u0642 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629\u060c \u0648\u0644\u064a\u0633 \u0628\u0639\u062f \u0630\u0644\u0643.<\/p>\n<p><strong>\u0646\u0639\u0645\u060c \u062a\u0635\u0631\u064a\u062d \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 \u0625\u0644\u0632\u0627\u0645\u064a \u0625\u0630\u0627 \u0643\u0627\u0646 \u0633\u064a\u062a\u0645 \u0628\u064a\u0639 \u0627\u0644\u062c\u0647\u0627\u0632 \u0623\u0648 \u062a\u0648\u0632\u064a\u0639\u0647 \u0623\u0648 \u0627\u0633\u062a\u062e\u062f\u0627\u0645\u0647 \u0644\u0623\u063a\u0631\u0627\u0636 \u0639\u0644\u0627\u062c\u064a\u0629 \u0641\u064a \u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629. \u0641\u0642\u0637 \u0639\u062f\u062f \u0642\u0644\u064a\u0644 \u0645\u0646 \u0627\u0644\u0645\u0648\u062f\u064a\u0644\u0627\u062a \u0645\u0646\u062e\u0641\u0636\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631 (\u0645\u062b\u0644 \u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u062a\u062f\u0644\u064a\u0643 \u0627\u0644\u0639\u0627\u0645\u0629) \u0645\u0639\u0641\u0627\u0629.<\/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=\"\u0636\u0628\u0627\u0637 \u0627\u0644\u062c\u0645\u0627\u0631\u0643 \u064a\u0641\u062d\u0635\u0648\u0646 \u0634\u062d\u0646\u0629 \u062c\u0647\u0627\u0632 \u0637\u0628\u064a \u0641\u064a \u0627\u0644\u0645\u0633\u062a\u0648\u062f\u0639 (ID#2)\" title=\"\u0641\u062d\u0635 \u0627\u0644\u062c\u0645\u0627\u0631\u0643\" \/><\/p>\n<p>\u0644\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0645\u0633\u0627\u0631\u0627\u062a \u0627\u0644\u062a\u0635\u0631\u064a\u062d \u0648\u0641\u0626\u0627\u062a \u0627\u0644\u0645\u062e\u0627\u0637\u0631\u060c \u0631\u0627\u062c\u0639 <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/classify-your-medical-device\">\u0646\u0638\u0627\u0645 \u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u062a\u0627\u0628\u0639 \u0644\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629<\/a><\/strong> <sup><a href=\"#footnote-1\" id=\"ref-1\">1<\/a><\/sup>.<br \/>\n\u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f\u064a\u0646 \u0623\u064a\u0636\u064b\u0627 \u0645\u0631\u0627\u062c\u0639\u0629 <strong><a href=\"https:\/\/www.fda.gov\/industry\/import-basics\/medical-devices\">\u0623\u0633\u0627\u0633\u064a\u0627\u062a \u0627\u0633\u062a\u064a\u0631\u0627\u062f \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u062a\u0627\u0628\u0639\u0629 \u0644\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629<\/a><\/strong> <sup><a href=\"#footnote-2\" id=\"ref-2\">2<\/a><\/sup> \u0644\u0641\u0647\u0645 \u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0648\u0627\u0644\u0631\u0642\u0627\u0628\u0629 \u0627\u0644\u062c\u0645\u0631\u0643\u064a\u0629.<\/p>\n<h3>\u0646\u0638\u0631\u0629 \u0639\u0627\u0645\u0629 \u0639\u0644\u0649 \u062a\u0635\u0646\u064a\u0641\u0627\u062a \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0645\u0642\u0635\u0648\u062f \/ \u0646\u0648\u0639 \u0627\u0644\u0645\u0648\u062f\u064a\u0644<\/th>\n<th>\u0641\u0626\u0629 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621<\/th>\n<th>\u0646\u0648\u0639 \u0627\u0644\u062a\u0635\u0631\u064a\u062d<\/th>\n<th>\u0645\u062b\u0627\u0644 \u0644\u0631\u0645\u0632 \u0627\u0644\u0645\u0646\u062a\u062c<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u0627\u0644\u0639\u0644\u0627\u062c \u0627\u0644\u0639\u0636\u0644\u064a \u0627\u0644\u0647\u064a\u0643\u0644\u064a (\u0645\u062b\u0644 \u0627\u0644\u062a\u0647\u0627\u0628 \u0627\u0644\u0623\u0648\u062a\u0627\u0631\u060c \u062a\u062e\u0641\u064a\u0641 \u0627\u0644\u0623\u0644\u0645)<\/td>\n<td>\u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0646\u064a\u0629<\/td>\n<td>510(k)<\/td>\n<td><strong>NPV<\/strong>, <strong>ISA<\/strong><\/td>\n<\/tr>\n<tr>\n<td>\u0639\u0644\u0627\u062c \u0627\u0644\u062c\u0631\u0648\u062d \u0627\u0644\u0645\u0632\u0645\u0646\u0629<\/td>\n<td>\u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0646\u064a\u0629<\/td>\n<td>510(k)<\/td>\n<td><strong>PZL<\/strong><\/td>\n<\/tr>\n<tr>\n<td>\u062a\u0641\u062a\u064a\u062a \u0627\u0644\u062d\u0635\u0648\u0627\u062a (\u062a\u0641\u062a\u064a\u062a \u062d\u0635\u0648\u0627\u062a \u0627\u0644\u0643\u0644\u0649)<\/td>\n<td>\u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u062b\u0627\u0644\u062b\u0629<\/td>\n<td>PMA<\/td>\n<td><strong>78F<\/strong>, <strong>LITH<\/strong><\/td>\n<\/tr>\n<tr>\n<td>\u0627\u0644\u0627\u0647\u062a\u0632\u0627\u0632 \u0623\u0648 \u0627\u0644\u062a\u062f\u0644\u064a\u0643 \u0645\u0646\u062e\u0641\u0636 \u0627\u0644\u0637\u0627\u0642\u0629 (\u0627\u062f\u0639\u0627\u0621\u0627\u062a \u063a\u064a\u0631 \u0637\u0628\u064a\u0629)<\/td>\n<td>\u0627\u0644\u0641\u0626\u0629 \u0627\u0644\u0623\u0648\u0644\u0649<\/td>\n<td>\u0645\u0639\u0641\u0649 (\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0639\u0627\u0645)<\/td>\n<td><strong>890.5660<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>\u0645\u0627\u0630\u0627 \u064a\u062d\u062f\u062b \u0628\u062f\u0648\u0646 \u0645\u0648\u0627\u0641\u0642\u0629 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 (FDA)<\/h3>\n<p>\u0625\u0630\u0627 \u0648\u0635\u0644 \u062c\u0647\u0627\u0632 \u0645\u0633\u062a\u0648\u0631\u062f \u0628\u062f\u0648\u0646 \u0645\u0648\u0627\u0641\u0642\u0629 510(k) \u0635\u0627\u0644\u062d\u0629 \u0623\u0648 \u0625\u0639\u0641\u0627\u0621\u060c \u0642\u062f \u062a\u0642\u0648\u0645 \u0627\u0644\u062c\u0645\u0627\u0631\u0643 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 \u0648\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0628\u0645\u0627 \u064a\u0644\u064a:<\/p>\n<ul>\n<li><strong>\u0627\u062d\u062a\u062c\u0627\u0632 \u0627\u0644\u0634\u062d\u0646\u0629<\/strong> \u0641\u064a \u0627\u0644\u0645\u064a\u0646\u0627\u0621 (\u0627\u0646\u0638\u0631 <a href=\"https:\/\/www.accessdata.fda.gov\/cms_ia\/default.cfm\">\u062a\u0646\u0628\u064a\u0647\u0627\u062a \u0627\u0644\u0627\u0633\u062a\u064a\u0631\u0627\u062f<\/a>) <sup><a href=\"#footnote-3\" id=\"ref-3\">3<\/a><\/sup>.  <\/li>\n<li><strong>\u0631\u0641\u0636 \u0627\u0644\u062f\u062e\u0648\u0644 \u0623\u0648 \u0625\u062a\u0644\u0627\u0641<\/strong> \u0627\u0644\u062c\u0647\u0627\u0632.  <\/li>\n<li><strong>\u0625\u062f\u0631\u0627\u062c \u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0623\u0648 \u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f \u0641\u064a \u0627\u0644\u0642\u0627\u0626\u0645\u0629 \u0627\u0644\u0633\u0648\u062f\u0627\u0621<\/strong> \u0644\u0644\u0648\u0627\u0631\u062f\u0627\u062a \u0627\u0644\u0645\u0633\u062a\u0642\u0628\u0644\u064a\u0629.<\/li>\n<\/ul>\n<p>\u062d\u062a\u0649 \u0648\u062d\u062f\u0627\u062a \u0627\u0644\u0639\u0631\u0636 \u0623\u0648 \u0634\u062d\u0646\u0627\u062a \u0627\u0644\u0639\u064a\u0646\u0627\u062a \u064a\u062c\u0628 \u0623\u0646 \u062a\u062a\u0636\u0645\u0646 \u0648\u062b\u0627\u0626\u0642 \u062a\u062d\u062f\u062f \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u063a\u064a\u0631 \u0627\u0644\u0633\u0631\u064a\u0631\u064a (\u0639\u0644\u0649 \u0633\u0628\u064a\u0644 \u0627\u0644\u0645\u062b\u0627\u0644\u060c \u201c\u0644\u0644\u0645\u0639\u0627\u0631\u0636 \u0641\u0642\u0637\u201d).<\/p>\n<hr \/>\n<h2>\u0643\u064a\u0641\u064a\u0629 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629<\/h2>\n<p>\u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0645\u0634\u062a\u0631\u064a\u0646 \u062f\u0627\u0626\u0645\u064b\u0627 \u0627\u0644\u062a\u0623\u0643\u062f \u0645\u0645\u0627 \u0625\u0630\u0627 \u0643\u0627\u0646 \u0646\u0645\u0648\u0630\u062c \u0627\u0644\u0645\u0648\u0631\u062f \u0642\u062f \u062d\u0635\u0644 \u0639\u0644\u0649 \u0645\u0648\u0627\u0641\u0642\u0629 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0642\u0628\u0644 \u0627\u0644\u0634\u0631\u0627\u0621. \u064a\u0645\u0643\u0646 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0630\u0644\u0643 \u0639\u0644\u0646\u064b\u0627.<\/p>\n<p><strong>\u064a\u0645\u0643\u0646\u0643 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0645\u0648\u0627\u0641\u0642\u0629 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0639\u0646 \u0637\u0631\u064a\u0642 \u0641\u062d\u0635 \u0627\u0644\u0645\u0648\u0642\u0639 \u0627\u0644\u0631\u0633\u0645\u064a <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm\">\u0642\u0627\u0639\u062f\u0629 \u0628\u064a\u0627\u0646\u0627\u062a FDA 510(k)<\/a><\/strong> <sup><a href=\"#footnote-4\" id=\"ref-4\">4<\/a><\/sup><br \/>\n\u0623\u0648 <strong><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfRL\/rl.cfm\">\u0642\u0627\u0639\u062f\u0629 \u0628\u064a\u0627\u0646\u0627\u062a \u062a\u0633\u062c\u064a\u0644 \u0627\u0644\u0645\u0646\u0634\u0623\u0629 \u0648\u0642\u0627\u0626\u0645\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629<\/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=\"\u0645\u0633\u0624\u0648\u0644 \u062a\u0646\u0638\u064a\u0645\u064a \u064a\u0631\u0627\u062c\u0639 \u0648\u062b\u0627\u0626\u0642 \u0637\u0644\u0628 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 (ID#3)\" title=\"\u0639\u0645\u0644\u064a\u0629 \u0645\u0631\u0627\u062c\u0639\u0629 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629\" \/><\/p>\n<p>\u0625\u0630\u0627 \u0644\u0645 \u064a\u0643\u0646 \u0644\u062f\u0649 \u0627\u0644\u0646\u0645\u0648\u0630\u062c \u0623\u064a \u0645\u0633\u0646\u062f\u060c \u0641\u0642\u062f \u064a\u062a\u0637\u0644\u0628 <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/selecting-de-novo-direct-class-ii-route-de-novo-classification\">\u062a\u0635\u0646\u064a\u0641 \u062f\u064a \u0646\u0648\u0641\u0648<\/a><\/strong> <sup><a href=\"#footnote-6\" id=\"ref-6\">6<\/a><\/sup> \u0628\u062f\u0644\u0627\u064b \u0645\u0646 510(k) \u0642\u064a\u0627\u0633\u064a.<\/p>\n<h3>\u0642\u0627\u0626\u0645\u0629 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0635\u062d\u0629<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u062e\u0637\u0648\u0629<\/th>\n<th>\u0645\u0627 \u064a\u062c\u0628 \u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646\u0647<\/th>\n<th>\u0645\u062b\u0627\u0644 \u0625\u062f\u062e\u0627\u0644<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>1<\/td>\n<td>\u0631\u0642\u0645 \u062a\u0633\u062c\u064a\u0644 \u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0644\u062f\u0649 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621<\/td>\n<td>\u0645\u062b\u0627\u0644: 3012345678<\/td>\n<\/tr>\n<tr>\n<td>2<\/td>\n<td>\u0642\u0627\u0626\u0645\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0645\u0639 \u0631\u0645\u0632 \u0627\u0644\u0645\u0646\u062a\u062c \u0627\u0644\u0635\u062d\u064a\u062d<\/td>\n<td>\u201cPZL \u2013 \u062c\u0647\u0627\u0632\u060c \u0645\u0648\u062c\u0629 \u0635\u0627\u062f\u0645\u0629\u060c \u0644\u0627\u0644\u062a\u0626\u0627\u0645 \u0627\u0644\u062c\u0631\u0648\u062d\u201d<\/td>\n<\/tr>\n<tr>\n<td>3<\/td>\n<td>\u0631\u0642\u0645 510(k) \u0648\u062a\u0627\u0631\u064a\u062e \u0627\u0644\u0642\u0631\u0627\u0631<\/td>\n<td>\u0645\u062b\u0627\u0644:, <strong>K202112<\/strong> (\u062a\u0645 \u0627\u0644\u062a\u062e\u0644\u064a\u0635 \u0639\u0646\u0647 2021)<\/td>\n<\/tr>\n<tr>\n<td>4<\/td>\n<td>\u0648\u0643\u064a\u0644 \u0623\u0648 \u0645\u0633\u062a\u0648\u0631\u062f \u0623\u0645\u0631\u064a\u0643\u064a \u0645\u062f\u0631\u062c<\/td>\n<td>\u0645\u0633\u062c\u0644 \u062a\u062d\u062a \u0646\u0641\u0633 \u0627\u0633\u0645 \u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>\u0639\u0644\u0627\u0645\u0627\u062a \u062d\u0645\u0631\u0627\u0621<\/h3>\n<ul>\n<li>\u064a\u0642\u062f\u0645 \u0627\u0644\u0645\u0648\u0631\u062f \u201c\u0634\u0647\u0627\u062f\u0629 CE\u201d \u0641\u0642\u0637.\u201d  <\/li>\n<li>\u0631\u0642\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0644\u0627 \u064a\u062a\u0637\u0627\u0628\u0642 \u0645\u0639 \u0627\u0633\u0645 \u0627\u0644\u0634\u0631\u0643\u0629.  <\/li>\n<li>\u062a\u062f\u0639\u064a \u201c\u0645\u0633\u062c\u0644\u0629 \u0644\u062f\u0649 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621\u201d \u062f\u0648\u0646 \u062f\u0644\u064a\u0644 \u0639\u0644\u0649 \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629.<\/li>\n<\/ul>\n<p>\u0627\u0644\u062a\u0633\u062c\u064a\u0644 \u0644\u0627 \u064a\u0639\u0646\u064a \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629. \u0641\u0642\u0637 \u062e\u0637\u0627\u0628 510(k) \u0631\u0633\u0645\u064a \u064a\u0624\u0643\u062f \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u062a\u0633\u0648\u064a\u0642 \u0641\u064a \u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629.<\/p>\n<hr \/>\n<h2>\u0645\u0627 \u0647\u064a \u0627\u0644\u0645\u0633\u062a\u0646\u062f\u0627\u062a \u0627\u0644\u062a\u064a \u062a\u062b\u0628\u062a \u0645\u0648\u0627\u0641\u0642\u0629 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629\u061f<\/h2>\n<p>\u062d\u0633\u0628 \u062e\u0628\u0631\u062a\u064a\u060c \u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0645\u0634\u062a\u0631\u064a\u0646 \u0637\u0644\u0628 \u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u062a\u0627\u0644\u064a\u0629 \u0644\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0642\u0628\u0644 \u0627\u0644\u0634\u062d\u0646.<\/p>\n<p><strong>\u062a\u0634\u0645\u0644 \u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u062a\u064a \u062a\u062b\u0628\u062a \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u062e\u0637\u0627\u0628 \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 510(k)\u060c \u0648\u0633\u062c\u0644 \u0642\u0627\u0626\u0645\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629\u060c \u0648\u0634\u0647\u0627\u062f\u0629 \u062a\u0633\u062c\u064a\u0644 \u0627\u0644\u0645\u0646\u0634\u0623\u0629\u060c \u0648\u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a \u0627\u0644\u062a\u064a \u062a\u062a\u0637\u0627\u0628\u0642 \u0645\u0639 \u0627\u0644\u0645\u0624\u0634\u0631 \u0627\u0644\u0645\u0639\u062a\u0645\u062f.<\/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=\"\u0648\u062b\u064a\u0642\u0629 \u0645\u0648\u0627\u0641\u0642\u0629 FDA 510(k) \u0645\u0648\u0642\u0639\u0629 \u0639\u0644\u0649 \u0627\u0644\u0645\u0643\u062a\u0628 (ID#4)\" title=\"\u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 \u0639\u0644\u0649 510k\" \/><\/p>\n<p>\u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0645\u0634\u062a\u0631\u064a\u0646 \u0641\u064a \u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629 \u0623\u064a\u0636\u064b\u0627 \u0636\u0645\u0627\u0646 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0640 <strong><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-820\">21 CFR Part 820 \u0644\u0627\u0626\u062d\u0629 \u0646\u0638\u0627\u0645 \u0627\u0644\u062c\u0648\u062f\u0629<\/a><\/strong> <sup><a href=\"#footnote-7\" id=\"ref-7\">7<\/a><\/sup> \u0648<br \/>\n<strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/labeling-requirements\">\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a \u0627\u0644\u062e\u0627\u0635\u0629 \u0628\u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0645\u0646 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621<\/a><\/strong> <sup><a href=\"#footnote-8\" id=\"ref-8\">8<\/a><\/sup>.<\/p>\n<h3>\u0642\u0627\u0626\u0645\u0629 \u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u0623\u0633\u0627\u0633\u064a\u0629 \u0644\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u0627\u0633\u0645 \u0627\u0644\u0648\u062b\u064a\u0642\u0629<\/th>\n<th>\u0627\u0644\u063a\u0631\u0636 \/ \u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u062a\u062d\u0642\u0642<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>\u062e\u0637\u0627\u0628 \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 510(k) \u0645\u0646 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621<\/strong><\/td>\n<td>\u062a\u0623\u0643\u064a\u062f \u0631\u0633\u0645\u064a \u0644\u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u062a\u0633\u0648\u064a\u0642.<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0633\u062c\u0644 \u0642\u0627\u0626\u0645\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629<\/strong><\/td>\n<td>\u064a\u0639\u0631\u0636 \u0627\u0633\u0645 \u0627\u0644\u0645\u0646\u062a\u062c \u0648\u0627\u0644\u0641\u0626\u0629 \u0648\u062a\u0633\u062c\u064a\u0644 \u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629.<\/td>\n<\/tr>\n<tr>\n<td><strong>\u062a\u0633\u062c\u064a\u0644 \u0627\u0644\u0645\u0646\u0634\u0623\u0629<\/strong><\/td>\n<td>\u064a\u0624\u0643\u062f \u062a\u0633\u062c\u064a\u0644 \u0627\u0644\u0645\u0635\u0646\u0639 \u0627\u0644\u0623\u062c\u0646\u0628\u064a \u0648\u0627\u0644\u0648\u0643\u064a\u0644 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a.<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0648\u0631\u0642\u0629 \u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a \u0648\u0627\u0644\u0645\u0624\u0634\u0631\u0627\u062a<\/strong><\/td>\n<td>\u064a\u062c\u0628 \u0623\u0646 \u062a\u062a\u0637\u0627\u0628\u0642 \u0645\u0639 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0645\u0642\u0635\u0648\u062f \u0627\u0644\u0645\u0639\u062a\u0645\u062f \u0645\u0646 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621.<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0634\u0647\u0627\u062f\u0629 \u0646\u0638\u0627\u0645 \u0627\u0644\u062c\u0648\u062f\u0629 (21 CFR 820)<\/strong><\/td>\n<td>\u062a\u062b\u0628\u062a \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u062a\u0635\u0646\u064a\u0639.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>\u0633\u0648\u0621 \u0627\u0644\u0641\u0647\u0645 \u0627\u0644\u0634\u0627\u0626\u0639<\/h3>\n<ul>\n<li>\u064a\u0645\u0643\u0646 \u0623\u0646 \u062a\u0643\u0648\u0646 \u0627\u0644\u0634\u0631\u0643\u0629 \u201c\u0645\u0633\u062c\u0644\u0629 \u0644\u062f\u0649 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621\u201d \u062f\u0648\u0646 \u0623\u0646 \u064a\u0643\u0648\u0646 <strong>\u062c\u0647\u0627\u0632\u0647\u0627<\/strong> \u0645\u0639\u062a\u0645\u062f\u064b\u0627.  <\/li>\n<li>\u0634\u0647\u0627\u062f\u0629 CE \u0623\u0648 ISO 13485 <strong>\u0644\u064a\u0633\u062a \u0628\u062f\u0627\u0626\u0644<\/strong> \u0644\u0644\u0645\u0648\u0627\u0641\u0642\u0629 \u0645\u0646 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621.  <\/li>\n<li>\u064a\u062a\u0637\u0644\u0628 \u0643\u0644 \u0646\u0645\u0648\u0630\u062c \u0631\u0642\u0645 510(k) \u0627\u0644\u062e\u0627\u0635 \u0628\u0647.<\/li>\n<\/ul>\n<p>\u064a\u0645\u0643\u0646 \u0627\u0644\u0639\u062b\u0648\u0631 \u0639\u0644\u0649 \u0627\u0644\u0645\u0632\u064a\u062f \u062d\u0648\u0644 \u0623\u062f\u0648\u0627\u0631 \u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f \u0641\u064a <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/establishment-registration-medical-devices\">\u0625\u0631\u0634\u0627\u062f\u0627\u062a \u062a\u0633\u062c\u064a\u0644 \u0627\u0644\u0645\u0646\u0634\u0622\u062a \u0644\u062f\u0649 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621<\/a><\/strong> <sup><a href=\"#footnote-9\" id=\"ref-9\">9<\/a><\/sup>.<\/p>\n<hr \/>\n<h2>\u0647\u0644 \u062a\u0646\u0637\u0628\u0642 \u0642\u0648\u0627\u0639\u062f \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 \u0639\u0644\u0649 \u062c\u0645\u064a\u0639 \u0627\u0644\u0645\u0648\u062f\u064a\u0644\u0627\u062a\u061f<\/h2>\n<p>\u0644\u0627 \u064a\u062a\u0645 \u062a\u0646\u0638\u064a\u0645 \u062c\u0645\u064a\u0639 \u0623\u0646\u0638\u0645\u0629 \u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0628\u0646\u0641\u0633 \u0627\u0644\u0637\u0631\u064a\u0642\u0629. \u064a\u0639\u062a\u0645\u062f \u0627\u0644\u062a\u0635\u0646\u064a\u0641 \u0639\u0644\u0649 <strong>\u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0637\u0628\u064a \u0627\u0644\u0645\u0642\u0635\u0648\u062f<\/strong>, <strong>\u0645\u0633\u062a\u0648\u0649 \u0627\u0644\u0637\u0627\u0642\u0629<\/strong>, \u0648 <strong>\u0627\u062f\u0639\u0627\u0621\u0627\u062a \u0627\u0644\u062a\u0633\u0648\u064a\u0642<\/strong>.<\/p>\n<p><strong>\u0646\u0639\u0645\u060c \u062a\u062e\u0636\u0639 \u062c\u0645\u064a\u0639 \u0627\u0644\u0645\u0648\u062f\u064a\u0644\u0627\u062a \u0627\u0644\u0645\u0628\u0627\u0639\u0629 \u0623\u0648 \u0627\u0644\u0645\u0633\u062a\u062e\u062f\u0645\u0629 \u0644\u0644\u0623\u063a\u0631\u0627\u0636 \u0627\u0644\u0637\u0628\u064a\u0629 \u0641\u064a \u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629 \u0644\u0642\u0648\u0627\u0639\u062f \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 (FDA) - \u0648\u0644\u0643\u0646 \u0642\u062f \u062a\u064f\u0639\u0641\u0649 \u0645\u0648\u062f\u064a\u0644\u0627\u062a \u201c\u0627\u0644\u062a\u062f\u0644\u064a\u0643\u201d \u0645\u0646\u062e\u0641\u0636\u0629 \u0627\u0644\u0637\u0627\u0642\u0629 \u0625\u0630\u0627 \u0644\u0645 \u064a\u062a\u0645 \u062a\u0642\u062f\u064a\u0645 \u0623\u064a \u0627\u062f\u0639\u0627\u0621\u0627\u062a \u0637\u0628\u064a\u0629.<\/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=\"\u062a\u0634\u0643\u064a\u0644\u0629 \u0645\u0646 \u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0645\u0639 \u0623\u063a\u0631\u0627\u0636 \u0645\u062d\u062f\u062f\u0629 (ID#5)\" title=\"\u062e\u0637 \u0625\u0646\u062a\u0627\u062c Shockwave\" \/><\/p>\n<p>\u0644\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0642\u0648\u0627\u0626\u0645 \u0627\u0644\u0625\u0639\u0641\u0627\u0621\u060c \u0631\u0627\u062c\u0639 <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/510k-exempt-devices\">\u062f\u0644\u064a\u0644 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0645\u0639\u0641\u0627\u0629 \u0645\u0646 510(k) \u0627\u0644\u062e\u0627\u0635 \u0628\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621<\/a><\/strong> <sup><a href=\"#footnote-10\" id=\"ref-10\">10<\/a><\/sup>.<\/p>\n<hr \/>\n<h2>\u0627\u0644\u062e\u0627\u062a\u0645\u0629<\/h2>\n<p>\u064a\u062c\u0628 \u0623\u0646 \u062a\u0645\u062a\u062b\u0644 \u0623\u064a \u0622\u0644\u0629 \u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u064a\u062a\u0645 \u0627\u0633\u062a\u064a\u0631\u0627\u062f\u0647\u0627 \u0625\u0644\u0649 \u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629 \u0644\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0633\u0631\u064a\u0631\u064a \u0644\u0644\u0648\u0627\u0626\u062d \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 (FDA) - \u0639\u0627\u062f\u0629\u064b \u0645\u0646 \u062e\u0644\u0627\u0644 \u0645\u0648\u0627\u0641\u0642\u0629 510(k) \u0623\u0648 PMA. \u062a\u062d\u0642\u0642 \u062f\u0627\u0626\u0645\u064b\u0627 \u0645\u0646 \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 \u0641\u064a \u0642\u0627\u0639\u062f\u0629 \u0628\u064a\u0627\u0646\u0627\u062a \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621\u060c \u0648\u0627\u0637\u0644\u0628 \u0627\u0644\u0645\u0633\u062a\u0646\u062f\u0627\u062a \u0627\u0644\u0631\u0633\u0645\u064a\u0629 \u0645\u0646 \u0627\u0644\u0645\u0648\u0631\u062f \u0627\u0644\u062e\u0627\u0635 \u0628\u0643\u060c \u0648\u062a\u0623\u0643\u062f \u0645\u0646 \u0623\u0646 \u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a \u0648\u0627\u0644\u062a\u0633\u0648\u064a\u0642 \u064a\u062a\u0637\u0627\u0628\u0642\u0627\u0646 \u0645\u0639 \u0627\u0644\u0645\u0624\u0634\u0631\u0627\u062a \u0627\u0644\u0645\u0639\u062a\u0645\u062f\u0629.<br \/>\n<strong>\u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u064a\u0633 \u0627\u062e\u062a\u064a\u0627\u0631\u064a\u064b\u0627 - \u0625\u0646\u0647 \u0623\u0633\u0627\u0633 \u0627\u0644\u0627\u0633\u062a\u064a\u0631\u0627\u062f \u0627\u0644\u0642\u0627\u0646\u0648\u0646\u064a \u0648\u0627\u0644\u062a\u0634\u063a\u064a\u0644 \u0627\u0644\u0622\u0645\u0646 \u0641\u064a \u0633\u0648\u0642 \u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629.<\/strong><\/p>\n<hr \/>\n<h2>\u0627\u0644\u062d\u0648\u0627\u0634\u064a<\/h2>\n<p><span id=\"footnote-1\">1. \u0646\u0638\u0631\u0629 \u0639\u0627\u0645\u0629 \u0639\u0644\u0649 \u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0644\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621. <a href=\"#ref-1\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-2\">2. \u062f\u0644\u064a\u0644 \u0627\u0644\u0627\u0633\u062a\u064a\u0631\u0627\u062f \u0627\u0644\u062e\u0627\u0635 \u0628\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0644\u0634\u062d\u0646\u0627\u062a \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629. <a href=\"#ref-2\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-3\">3. \u062a\u0646\u0628\u064a\u0647\u0627\u062a \u0627\u0644\u0627\u0633\u062a\u064a\u0631\u0627\u062f \u0627\u0644\u062e\u0627\u0635\u0629 \u0628\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0644\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u063a\u064a\u0631 \u0627\u0644\u0645\u062a\u0648\u0627\u0641\u0642\u0629. <a href=\"#ref-3\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-4\">4. \u0642\u0627\u0639\u062f\u0629 \u0628\u064a\u0627\u0646\u0627\u062a \u0627\u0644\u0628\u062d\u062b \u0639\u0646 \u0645\u0648\u0627\u0641\u0642\u0627\u062a 510(k) \u0627\u0644\u062e\u0627\u0635\u0629 \u0628\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621. <a href=\"#ref-4\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-5\">5. \u0642\u0627\u0639\u062f\u0629 \u0628\u064a\u0627\u0646\u0627\u062a \u062a\u0633\u062c\u064a\u0644 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u062e\u0627\u0635\u0629 \u0628\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621. <a href=\"#ref-5\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-6\">6. \u0645\u0633\u0627\u0631 \u0627\u0644\u062a\u0635\u0646\u064a\u0641 De Novo \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u062c\u062f\u064a\u062f\u0629. <a href=\"#ref-6\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-7\">7. \u0644\u0627\u0626\u062d\u0629 \u0646\u0638\u0627\u0645 \u0627\u0644\u062c\u0648\u062f\u0629 (21 CFR \u0627\u0644\u062c\u0632\u0621 820). <a href=\"#ref-7\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-8\">8. \u0642\u0648\u0627\u0639\u062f \u0627\u0644\u0645\u0644\u0635\u0642\u0627\u062a \u0648\u0627\u0644\u0645\u0624\u0634\u0631\u0627\u062a \u0627\u0644\u062e\u0627\u0635\u0629 \u0628\u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0644\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621. <a href=\"#ref-8\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-9\">9. \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u062a\u0633\u062c\u064a\u0644 \u0648\u0627\u0644\u0648\u0643\u064a\u0644 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a. <a href=\"#ref-9\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-10\">10. \u0642\u0627\u0626\u0645\u0629 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0628\u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0645\u0639\u0641\u0627\u0629 \u0645\u0646 510(k). <a href=\"#ref-10\">\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\/ar\/\u0647\u0644-\u064a\u062c\u0628-\u0623\u0646-\u062a\u0644\u0628\u064a-\u0623\u062c\u0647\u0632\u0629-\u0627\u0644\u0639\u0644\u0627\u062c-\u0628\u0627\u0644\u0635\u062f\u0645\u0627\u062a-\u0627\u0644\/\" \/>\n<meta property=\"og:locale\" content=\"ar_AR\" \/>\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. 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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\/ar\/\u0647\u0644-\u064a\u062c\u0628-\u0623\u0646-\u062a\u0644\u0628\u064a-\u0623\u062c\u0647\u0632\u0629-\u0627\u0644\u0639\u0644\u0627\u062c-\u0628\u0627\u0644\u0635\u062f\u0645\u0627\u062a-\u0627\u0644\/","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":{"\u0643\u064f\u062a\u0628 \u0628\u0648\u0627\u0633\u0637\u0629":"Sophia Wu","\u0648\u0642\u062a \u0627\u0644\u0642\u0631\u0627\u0621\u0629 \u0627\u0644\u0645\u064f\u0642\u062f\u0651\u0631":"5 \u062f\u0642\u0627\u0626\u0642"},"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":"ar","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":"\u0647\u0644 \u064a\u062c\u0628 \u0623\u0646 \u062a\u0644\u0628\u064a \u0622\u0644\u0627\u062a \u0627\u0644\u0639\u0644\u0627\u062c \u0628\u0627\u0644\u0645\u0648\u062c\u0627\u062a \u0627\u0644\u0635\u062f\u0645\u064a\u0629 \u0627\u0644\u0645\u0633\u062a\u0648\u0631\u062f\u0629 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0623\u0648 \u0634\u0647\u0627\u062f\u0627\u062a \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629\u061f - 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