510(k) Report

Devices descending from K121719

30 later devices reach SM Tens & PMS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201354Tens & PMSHong Qiangxing (Shenzhen) Electronics Limited20201—
+1K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited20190—
+1K133929Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited201426—
+2K241678TENS & EMS Stimulator (MHD-1083)Shenzhen Minghuangda Electronics Co., Ltd.20240—
+2K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+2K240292Transcutaneous Electrical Nerve Stimulator (9029SCM)Hong Kong Etech Groups Limited20240—
+2K232439Electrical Stimulator SystemGymmax Technology Shenzen Co., Ltd.20240—
+2K191982Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220…Shenzhen Kentro Medical Electronics Co., Ltd.20202—
+2K190783Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited20206—
+2K190673Health Expert Electronic StimulatorShenzhen Osto Technology Company Limited20191—
+2K183674Electronic Pulse StimulatorShenzhen Leading Perfection Technology Co., Ltd.20190—
+2K182136Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)Shenzhen Osto Technology Co., Ltd.20190—
+2K183103EMS Belt (Model MC0485)Dongguan Yingfeng Metal & Plastic Products Co., Ltd.20190—
+2K172897Neck Care Therapy, Model: SYK 509BShenzhen Osto Technology Co., Ltd.20183—
+2K172837Low-frequency Multi-function physiotherapy instrumentShenzhen Osto Technology Co., Ltd.20180—
+2K172834Dual output digital therapy massagerShenzhen Osto Technology Co., Ltd.20180—
+2K163611Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd.20172—
+2K170205Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203Shenzhen Kentro Medical Electronics Co., Ltd.20170—
+2K1521282-in-1 Abdominal Muscle Training & Back Pain Relief SystemTohkai Precision Electrical Manufactory (Shenzhen) Limited20150—
+3K230443TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)Jiangxi Royall Smart Technology Co., Ltd.20230—
+3K223428Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A…Shenzhen Leqing Medical Instrument Co., Ltd.20230—
+3K221092Transcutaneous Electrical Nerve Stimulator Model: ST-304Shenzhen Future Electronic Co., Ltd.20220—
+3K221251Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)Guangzhou Huakai Electronic Technology Co., Ltd.20220—
+3K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited20211—
+3K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+3K200558Smart Neck StimulatorGuandong Skg Intelligent Technology Co., Ltd.20210—
+3K211736Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V…Shenzhen Osto Technology Company Limited20210—
+3K210756Neck Care Therapy, Model: AST-905A, AST-905D, AST-905HShenzhen Osto Technology Company Limited20211—
+3K200177Low-frequency Multi-function physiotherapy instrumentShenzhen Kentro Medical Electronics Co., Ltd.20210—
+3K200237Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20200—