510(k) Report

Devices descending from K040512

82 later devices reach Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A, WL-2203B and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112392Hivox Biotek Inc.Hivox Biotek, Inc.201258—
+1K063660Otc Tens for Low Back Pain Relief, Model WL-2407Well-Life Healthcare Limited20073—
+1K060222Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PPGemore Technology Co, Ltd.200614—
+1K052785Otc Tens for Low Back Pain Relief, Model WL-2405 and WL-2406Well-Life Healthcare Limited20068—
+2K151693Dr-Ho's Foot Pad ElectrodeDrtv Asia, Ltd.20151—
+2K140650Hivox Electric Stimulator Otc TensHivox Biotek, Inc.20142—
+2K133723Otc PatchWell-Life Healthcare Limited20143—
+2K122744Prospera Otc Tens Electronic Pulse MassagerProspera Corporation201355—
+2K113321Tens Back Pain Relief SystemSavia Limited20122—
+2K110716Everyway Low Back Pain Relief SystemEveryway Medical Instruments Co.,Ltd20110—
+2K110390Etg 255 Combo Stimualtor, Ten 260 StimualtorHandelshaus Dittman GmbH20110—
+2K090042Painmaster MCT PatchNewmark, Inc.200911—
+3K242815Pocket Tens (EP-300)Hivox Biotek, Inc.20240—
+3K220524Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series)Well-Life Healthcare Limited20220—
+3K172887XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro -…Guangzhou Xinbo Electronic Co., Ltd.20180—
+3K162392AvazziaAvazzia, Inc.20170—
+3K160323FlowKeepersDk Electronics, LLC20170—
+3K160508Electronic Pulse StimulatorBeijing Choice Electronic Technololgy Co., Ltd.20162—
+3K151995Painmaster MCT PatchNewmark, Inc.20160—
+3K160893HANAROCare ReJuM.I.Tech Co., Ltd.20162—
+3K151034PainKARETriowave Technologies20150—
+3K151479EV-820 OTC Pain Relief TENSEveryway Medical Instruments Co.,Ltd20150—
+3K150681Gemore Otc TensGemore Technology Co, Ltd.20150—
+3K143207Revitive IX (OTC)Actegy, Ltd.201517—
+3K133929Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited201426—
+3K131933Electronic Pulse MassagerGurin Products, LLC20130—
+3K131921Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd.20136—
+3K130074Gymform Abs-a-RoundWell Brain International, Ltd.20133—
+3K130114Painmaster MCT PatchNewmark, Inc.20135—
+3K120500The Pain Pilot (a.K.a Pain Pilot)Hollywog, LLC20124—
+4K241678TENS & EMS Stimulator (MHD-1083)Shenzhen Minghuangda Electronics Co., Ltd.20240—
+4K240292Transcutaneous Electrical Nerve Stimulator (9029SCM)Hong Kong Etech Groups Limited20240—
+4K232439Electrical Stimulator SystemGymmax Technology Shenzen Co., Ltd.20240—
+4K221992Electronic Pulse StimulatorBeijing Choice Electronic Technology Co., Ltd.20220—
+4K202653Gymform Total ABSWell Brain International, Ltd.20210—
+4K200237Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20200—
+4K191982Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220…Shenzhen Kentro Medical Electronics Co., Ltd.20202—
+4K190783Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited20206—
+4K190673Health Expert Electronic StimulatorShenzhen Osto Technology Company Limited20191—
+4K183674Electronic Pulse StimulatorShenzhen Leading Perfection Technology Co., Ltd.20190—
+4K182136Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)Shenzhen Osto Technology Co., Ltd.20190—
+4K183103EMS Belt (Model MC0485)Dongguan Yingfeng Metal & Plastic Products Co., Ltd.20190—
+4K182267PAT (Pain Alleviation Technologies)Marchan Medical, LLC20190—
+4K172897Neck Care Therapy, Model: SYK 509BShenzhen Osto Technology Co., Ltd.20183—
+4K172837Low-frequency Multi-function physiotherapy instrumentShenzhen Osto Technology Co., Ltd.20180—
+4K172834Dual output digital therapy massagerShenzhen Osto Technology Co., Ltd.20180—
+4K163611Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd.20172—
+4K170205Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203Shenzhen Kentro Medical Electronics Co., Ltd.20170—
+4K170145Digital TENS UnitShenzhen Eapply Technology Co., Ltd.20170—
+4K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG2017111
+4K1521282-in-1 Abdominal Muscle Training & Back Pain Relief SystemTohkai Precision Electrical Manufactory (Shenzhen) Limited20150—
+4K152852ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Bayer Healthcare, LLC20152—
+4K142055Gymform Abs & CoreWell Brain International, Ltd.20151—
+4K133789Dolphin Neurostim OtcAcumed Medical, Ltd.20151—
+4K1335025000Z Firefly SystemPrizm Medical, Inc.20140—
+4K141260Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd.20145—
+5K243165Limfa Therapy System (Limfa Therapy)Eywa Srl20250—
+5K240348Quantum Mitohormesis (QMT) (M2101)Quantumtx Pte., Ltd.20240—
+5K231368Bemer Therapy System EvoBemer Int AG20230—
+5K230443TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)Jiangxi Royall Smart Technology Co., Ltd.20230—
+5K223428Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A…Shenzhen Leqing Medical Instrument Co., Ltd.20230—
+5K221092Transcutaneous Electrical Nerve Stimulator Model: ST-304Shenzhen Future Electronic Co., Ltd.20220—
+5K221251Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)Guangzhou Huakai Electronic Technology Co., Ltd.20220—
+5K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited20211—
+5K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+5K200558Smart Neck StimulatorGuandong Skg Intelligent Technology Co., Ltd.20210—
+5K211736Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V…Shenzhen Osto Technology Company Limited20210—
+5K210756Neck Care Therapy, Model: AST-905A, AST-905D, AST-905HShenzhen Osto Technology Company Limited20211—
+5K203710Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG20214—
+5K200177Low-frequency Multi-function physiotherapy instrumentShenzhen Kentro Medical Electronics Co., Ltd.20210—
+5K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG20215—
+5K200561StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd.20202—
+5K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited20190—
+5K182671Medi-Direct TENS PenJkh USA, LLC20190—
+5K181728Muscle TrainerShenzhen Kentro Medical Electronics Co., Ltd.20180—
+5K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)Bayer Healthcare, LLC20180—
+6K250896Aura WaveAura Wellness, LLC20251—
+6K240234BTL-899MSBTL Industries, Inc.20242—
+6K220938Nova HD+Aura Wellness, LLC20231—
+7K262788Nova HD+Aura Wellness, LLC20260—
+7K253408CoolToneZimmer Medizinsysteme GmbH20260—
+7K251594truFlexSyrma Johari Medtech Limited20250—