510(k) Report

Devices descending from K143207

17 later devices reach Revitive IX (OTC) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183103EMS Belt (Model MC0485)Dongguan Yingfeng Metal & Plastic Products Co., Ltd.20190—
+1K163611Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd.20172—
+1K160323FlowKeepersDk Electronics, LLC20170—
+1K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG2017111
+2K243165Limfa Therapy System (Limfa Therapy)Eywa Srl20250—
+2K240348Quantum Mitohormesis (QMT) (M2101)Quantumtx Pte., Ltd.20240—
+2K231368Bemer Therapy System EvoBemer Int AG20230—
+2K230443TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)Jiangxi Royall Smart Technology Co., Ltd.20230—
+2K203710Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG20214—
+2K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG20215—
+2K200237Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20200—
+3K250896Aura WaveAura Wellness, LLC20251—
+3K240234BTL-899MSBTL Industries, Inc.20242—
+3K220938Nova HD+Aura Wellness, LLC20231—
+4K262788Nova HD+Aura Wellness, LLC20260—
+4K253408CoolToneZimmer Medizinsysteme GmbH20260—
+4K251594truFlexSyrma Johari Medtech Limited20250—