510(k) Report

Devices descending from K940301

231 later devices reach Compex 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170659IQ TechnologiesIq Technologies, Inc.20170—
+4K162392AvazziaAvazzia, Inc.20170—
+4K170145Digital TENS UnitShenzhen Eapply Technology Co., Ltd.20170—
+4K160508Electronic Pulse StimulatorBeijing Choice Electronic Technololgy Co., Ltd.20162—
+4K161537OTC TENS Device, Model PTS-IVCounter Scientific Development (Gz), Ltd.20160—
+4K160255HBOTC Muscle and Nerve StimulatorHb Medical, Inc.20160—
+4K160893HANAROCare ReJuM.I.Tech Co., Ltd.20162—
+4K152852ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Bayer Healthcare, LLC20152—
+4K151903Slendertone connect AbsBio-Medical Research, Ltd.20151—
+4K151479EV-820 OTC Pain Relief TENSEveryway Medical Instruments Co.,Ltd20150—
+4K150681Gemore Otc TensGemore Technology Co, Ltd.20150—
+4K142506TensCare KegelFitTenscare, Ltd.20154—
+4K143207Revitive IX (OTC)Actegy, Ltd.201517—
+4K141978Maxpower ReliefOmron Healthcare, Inc.201410—
+4K1335025000Z Firefly SystemPrizm Medical, Inc.20140—
+4K133929Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited201426—
+4K141260Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd.20145—
+4K140168Easystim TN28_OtcEasymed Instruments Co., Ltd.20146—
+4K140650Hivox Electric Stimulator Otc TensHivox Biotek, Inc.20142—
+4K132993Counter Otc Tens DeviceCounter Scientific Development (Gz), Ltd.201426—
+4K131956Quick Relax ProHealthcare Innovations, LLC20140—
+4K133723Otc PatchWell-Life Healthcare Limited20143—
+4K131933Electronic Pulse MassagerGurin Products, LLC20130—
+4K131921Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd.20136—
+4K123866TANYXMedecell Us, Inc.20131—
+4K131159SmartreliefChattem, Inc.201332—
+4K121353Mini PatchWell-Life Healthcare Limited20121—
+4K112415Lifecare Arm & Leg Pain Relief SystemEveryway Medical Instruments Co.,Ltd20110—
+5K262353BTL-299-FBTL Industries, Inc.20260—
+5K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer…Hunan Accurate Bio-Medical Technology Co., Ltd.20260—
+5K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag20260—
+5K253636Zionic Pro Max (EMS)Termosalud S.L.20260—
+5K252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.20250—
+5K251026Regenesis EMS ChairTrinity Medical Solutions20250—
+5K242926XBody Go USA, XBody Pro USAXbody Hungary Kft.20250—
+5K250146SofWave SystemSofwave Medical, Ltd.20251—
+5K241516BTL-398BTL Industries, Inc.20250—
+5K242815Pocket Tens (EP-300)Hivox Biotek, Inc.20240—
+5K241678TENS & EMS Stimulator (MHD-1083)Shenzhen Minghuangda Electronics Co., Ltd.20240—
+5K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+5K240292Transcutaneous Electrical Nerve Stimulator (9029SCM)Hong Kong Etech Groups Limited20240—
+5K232439Electrical Stimulator SystemGymmax Technology Shenzen Co., Ltd.20240—
+5K233470Deka LilyEl.En S.P.A.20230—
+5K230780MFG-05Zimmer Medizinsysteme GmbH20230—
+5K230767Pelvic Floor Muscle StimulatorNanjing Vishee Medical Technology Co., Ltd.20230—
+5K223797Neuro20 Pro SystemNeuro20 Technologies20230—
+5K221992Electronic Pulse StimulatorBeijing Choice Electronic Technology Co., Ltd.20220—
+5K221498Miha Bodytec IIMiha Bodytec GmbH20220—
+5K220524Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series)Well-Life Healthcare Limited20220—
+5K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+5K200237Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20200—
+5K201845Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)Guangzhou Longest Science & Technology Co., Ltd.20200—
+5K191982Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220…Shenzhen Kentro Medical Electronics Co., Ltd.20202—
+5K200561StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd.20202—
+5K190783Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited20206—
+5K190966Katalyst Training SystemKatalyst, Inc.20203—
+5K190673Health Expert Electronic StimulatorShenzhen Osto Technology Company Limited20191—
+5K191312Perfect PFETenscare, Ltd.20193—
+5K183674Electronic Pulse StimulatorShenzhen Leading Perfection Technology Co., Ltd.20190—
+5K182136Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)Shenzhen Osto Technology Co., Ltd.20190—
+5K182671Medi-Direct TENS PenJkh USA, LLC20190—
+5K183103EMS Belt (Model MC0485)Dongguan Yingfeng Metal & Plastic Products Co., Ltd.20190—
+5K183288Transcutaneous Electrical Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20191—
+5K182120Maxpower ReliefOmron Healthcare, Inc.20190—
+5K172897Neck Care Therapy, Model: SYK 509BShenzhen Osto Technology Co., Ltd.20183—
+5K172837Low-frequency Multi-function physiotherapy instrumentShenzhen Osto Technology Co., Ltd.20180—
+5K181102ThermaCare Quick Therapy TENSPfizer, Inc.20180—
+5K172834Dual output digital therapy massagerShenzhen Osto Technology Co., Ltd.20180—
+5K180331Wireless Pain Relieve DeviceShenzhen Dongdixin Technology Co., Ltd.20180—
+5K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)Bayer Healthcare, LLC20180—
+5K172451Dr.MUSIC 3sSmartmedicaldevice Co., Ltd.20170—
+5K163611Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd.20172—
+5K170205Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203Shenzhen Kentro Medical Electronics Co., Ltd.20170—
+5K160323FlowKeepersDk Electronics, LLC20170—
+5K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG2017111
+5K161974SLENDERTONE® Connect Abs, Type 570Bio-Medical Research, Ltd.20160—
+5K153704StriveDjo, LLC201624—
+5K160115Heat Pain ProOmron Healthcare, Inc.20168—
+5K150386Tyece OTC TENS DeviceTyece, Ltd.201524—
+5K150043Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd.20151—
+5K143430SmartTENSEasy Med Instrument Co., Ltd.20151—
+6K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.20260—
+6K251760Well-Life Incontinence Stimulation System (WL-2405i (P))Well-Life Healthcare, Ltd.20260—
+6K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+6K251746Pure ImpactSofwave Medical, Ltd.20250—
+6K243165Limfa Therapy System (Limfa Therapy)Eywa Srl20250—
+6K233770Pepper EMS Training SystemPepper Interactive, Inc.20250—
+6K240348Quantum Mitohormesis (QMT) (M2101)Quantumtx Pte., Ltd.20240—
+6K230983Unicare (K-UNICARE-USA)Tenscare, Ltd.20230—
+6K231368Bemer Therapy System EvoBemer Int AG20230—
+6K230443TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)Jiangxi Royall Smart Technology Co., Ltd.20230—
+6K223428Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A…Shenzhen Leqing Medical Instrument Co., Ltd.20230—
+6K222386VisionbodyVb Technologies AG20230—
+6K222867AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd.20220—
+6K221092Transcutaneous Electrical Nerve Stimulator Model: ST-304Shenzhen Future Electronic Co., Ltd.20220—
+6K221251Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)Guangzhou Huakai Electronic Technology Co., Ltd.20220—
+6K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited20211—
+6K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+6K200558Smart Neck StimulatorGuandong Skg Intelligent Technology Co., Ltd.20210—
+6K211736Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V…Shenzhen Osto Technology Company Limited20210—