510(k) Report

Devices descending from K102598

78 later devices reach HI-Dow-XP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163393Hi-Dow Wireless TENS/EMS System (Model HD-5N)Hi-Dow International, Inc.20171—
+1K142686StimPad OTCAemed, Inc.20140—
+1K133979TENSSunmas (H.K.) Trading Limited20140—
+1K131290IQ TechnologiesIq Technologies, Inc.20148—
+1K132563Pinook StimulatorPinook USA20140—
+1K122410I Rune (I-200L)Medirune Co, Ltd.20130—
+1K121719SM Tens & PMSHong Qiangxing (Shenzhen) Electronics Limited201330—
+1K122744Prospera Otc Tens Electronic Pulse MassagerProspera Corporation201355—
+1K121757HealthmateforeverHealthmate International, LLC201222—
+2K241785StarFormer (M008-3T)Fotona D.O.O.20250—
+2K201354Tens & PMSHong Qiangxing (Shenzhen) Electronics Limited20201—
+2K193655MSLS6QF TENS/PMS DeviceSelf Doctor Care, LLC20200—
+2K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited20190—
+2K170659IQ TechnologiesIq Technologies, Inc.20170—
+2K162392AvazziaAvazzia, Inc.20170—
+2K170145Digital TENS UnitShenzhen Eapply Technology Co., Ltd.20170—
+2K160508Electronic Pulse StimulatorBeijing Choice Electronic Technololgy Co., Ltd.20162—
+2K161537OTC TENS Device, Model PTS-IVCounter Scientific Development (Gz), Ltd.20160—
+2K160893HANAROCare ReJuM.I.Tech Co., Ltd.20162—
+2K143207Revitive IX (OTC)Actegy, Ltd.201517—
+2K141978Maxpower ReliefOmron Healthcare, Inc.201410—
+2K133929Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited201426—
+2K141260Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd.20145—
+2K131956Quick Relax ProHealthcare Innovations, LLC20140—
+2K131910MPPMarc Pro20141—
+2K131933Electronic Pulse MassagerGurin Products, LLC20130—
+2K131921Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd.20136—
+2K130074Gymform Abs-a-RoundWell Brain International, Ltd.20133—
+3K241678TENS & EMS Stimulator (MHD-1083)Shenzhen Minghuangda Electronics Co., Ltd.20240—
+3K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+3K240292Transcutaneous Electrical Nerve Stimulator (9029SCM)Hong Kong Etech Groups Limited20240—
+3K232439Electrical Stimulator SystemGymmax Technology Shenzen Co., Ltd.20240—
+3K221992Electronic Pulse StimulatorBeijing Choice Electronic Technology Co., Ltd.20220—
+3K202653Gymform Total ABSWell Brain International, Ltd.20210—
+3K200237Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20200—
+3K191982Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220…Shenzhen Kentro Medical Electronics Co., Ltd.20202—
+3K200561StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd.20202—
+3K190783Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited20206—
+3K190673Health Expert Electronic StimulatorShenzhen Osto Technology Company Limited20191—
+3K183674Electronic Pulse StimulatorShenzhen Leading Perfection Technology Co., Ltd.20190—
+3K182136Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)Shenzhen Osto Technology Co., Ltd.20190—
+3K182671Medi-Direct TENS PenJkh USA, LLC20190—
+3K183103EMS Belt (Model MC0485)Dongguan Yingfeng Metal & Plastic Products Co., Ltd.20190—
+3K182120Maxpower ReliefOmron Healthcare, Inc.20190—
+3K172897Neck Care Therapy, Model: SYK 509BShenzhen Osto Technology Co., Ltd.20183—
+3K172837Low-frequency Multi-function physiotherapy instrumentShenzhen Osto Technology Co., Ltd.20180—
+3K172834Dual output digital therapy massagerShenzhen Osto Technology Co., Ltd.20180—
+3K163611Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd.20172—
+3K170205Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203Shenzhen Kentro Medical Electronics Co., Ltd.20170—
+3K160323FlowKeepersDk Electronics, LLC20170—
+3K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG2017111
+3K160255HBOTC Muscle and Nerve StimulatorHb Medical, Inc.20160—
+3K160115Heat Pain ProOmron Healthcare, Inc.20168—
+3K1521282-in-1 Abdominal Muscle Training & Back Pain Relief SystemTohkai Precision Electrical Manufactory (Shenzhen) Limited20150—
+3K142055Gymform Abs & CoreWell Brain International, Ltd.20151—
+4K243165Limfa Therapy System (Limfa Therapy)Eywa Srl20250—
+4K240348Quantum Mitohormesis (QMT) (M2101)Quantumtx Pte., Ltd.20240—
+4K231368Bemer Therapy System EvoBemer Int AG20230—
+4K230443TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)Jiangxi Royall Smart Technology Co., Ltd.20230—
+4K223428Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A…Shenzhen Leqing Medical Instrument Co., Ltd.20230—
+4K221092Transcutaneous Electrical Nerve Stimulator Model: ST-304Shenzhen Future Electronic Co., Ltd.20220—
+4K221251Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)Guangzhou Huakai Electronic Technology Co., Ltd.20220—
+4K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited20211—
+4K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+4K200558Smart Neck StimulatorGuandong Skg Intelligent Technology Co., Ltd.20210—
+4K211736Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V…Shenzhen Osto Technology Company Limited20210—
+4K210756Neck Care Therapy, Model: AST-905A, AST-905D, AST-905HShenzhen Osto Technology Company Limited20211—
+4K203710Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG20214—
+4K200177Low-frequency Multi-function physiotherapy instrumentShenzhen Kentro Medical Electronics Co., Ltd.20210—
+4K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG20215—
+4K181992Heat Pain ProOmron Healthcare, Inc.20180—
+4K181728Muscle TrainerShenzhen Kentro Medical Electronics Co., Ltd.20180—
+5K250896Aura WaveAura Wellness, LLC20251—
+5K240234BTL-899MSBTL Industries, Inc.20242—
+5K220938Nova HD+Aura Wellness, LLC20231—
+6K262788Nova HD+Aura Wellness, LLC20260—
+6K253408CoolToneZimmer Medizinsysteme GmbH20260—
+6K251594truFlexSyrma Johari Medtech Limited20250—