510(k) Report

Devices descending from K011880

195 later devices reach Compex Sport through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K131159SmartreliefChattem, Inc.201332—
+3K121353Mini PatchWell-Life Healthcare Limited20121—
+3K112415Lifecare Arm & Leg Pain Relief SystemEveryway Medical Instruments Co.,Ltd20110—
+4K253636Zionic Pro Max (EMS)Termosalud S.L.20260—
+4K252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.20250—
+4K242926XBody Go USA, XBody Pro USAXbody Hungary Kft.20250—
+4K250146SofWave SystemSofwave Medical, Ltd.20251—
+4K242815Pocket Tens (EP-300)Hivox Biotek, Inc.20240—
+4K241678TENS & EMS Stimulator (MHD-1083)Shenzhen Minghuangda Electronics Co., Ltd.20240—
+4K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+4K240292Transcutaneous Electrical Nerve Stimulator (9029SCM)Hong Kong Etech Groups Limited20240—
+4K232439Electrical Stimulator SystemGymmax Technology Shenzen Co., Ltd.20240—
+4K233470Deka LilyEl.En S.P.A.20230—
+4K223797Neuro20 Pro SystemNeuro20 Technologies20230—
+4K221992Electronic Pulse StimulatorBeijing Choice Electronic Technology Co., Ltd.20220—
+4K221498Miha Bodytec IIMiha Bodytec GmbH20220—
+4K220524Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series)Well-Life Healthcare Limited20220—
+4K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+4K200237Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20200—
+4K201845Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)Guangzhou Longest Science & Technology Co., Ltd.20200—
+4K191982Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220…Shenzhen Kentro Medical Electronics Co., Ltd.20202—
+4K200561StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd.20202—
+4K190783Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited20206—
+4K190966Katalyst Training SystemKatalyst, Inc.20203—
+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—
+4K182671Medi-Direct TENS PenJkh USA, LLC20190—
+4K183103EMS Belt (Model MC0485)Dongguan Yingfeng Metal & Plastic Products Co., Ltd.20190—
+4K183288Transcutaneous Electrical Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20191—
+4K182120Maxpower ReliefOmron Healthcare, Inc.20190—
+4K172897Neck Care Therapy, Model: SYK 509BShenzhen Osto Technology Co., Ltd.20183—
+4K172837Low-frequency Multi-function physiotherapy instrumentShenzhen Osto Technology Co., Ltd.20180—
+4K181102ThermaCare Quick Therapy TENSPfizer, Inc.20180—
+4K172834Dual output digital therapy massagerShenzhen Osto Technology Co., Ltd.20180—
+4K180331Wireless Pain Relieve DeviceShenzhen Dongdixin Technology Co., Ltd.20180—
+4K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)Bayer Healthcare, LLC20180—
+4K172451Dr.MUSIC 3sSmartmedicaldevice Co., Ltd.20170—
+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—
+4K160323FlowKeepersDk Electronics, LLC20170—
+4K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG2017111
+4K161974SLENDERTONE® Connect Abs, Type 570Bio-Medical Research, Ltd.20160—
+4K153704StriveDjo, LLC201624—
+4K160115Heat Pain ProOmron Healthcare, Inc.20168—
+4K150386Tyece OTC TENS DeviceTyece, Ltd.201524—
+4K150043Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd.20151—
+4K143430SmartTENSEasy Med Instrument Co., Ltd.20151—
+5K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+5K251746Pure ImpactSofwave Medical, Ltd.20250—
+5K243165Limfa Therapy System (Limfa Therapy)Eywa Srl20250—
+5K233770Pepper EMS Training SystemPepper Interactive, Inc.20250—
+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—
+5K222386VisionbodyVb Technologies AG20230—
+5K222867AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd.20220—
+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—
+5K182203JKH Stimulator PlusJkh USA, LLC20197—
+5K181992Heat Pain ProOmron Healthcare, Inc.20180—
+5K171803HIVOX OTC Electrical StimulatorHivox Biotek, Inc.201721—
+6K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.20260—
+6K252767actiTENS miniSublimed20260—
+6K250896Aura WaveAura Wellness, LLC20251—
+6K242460Progenix Select StimProgenix, LLC20250—
+6K240234BTL-899MSBTL Industries, Inc.20242—
+6K220938Nova HD+Aura Wellness, LLC20231—
+6K202866TENS & EMS DeviceShenzhen Jian Feng Electronic Technology Co., Ltd.20213—
+6K202159actiTENSSublimed20201—
+6K191151JKH Stimulator PlusJkh USA, LLC20194—
+6K190347HIVOX OTC Electrical StimulatorHivox Biotek, Inc.20198—
+7K262788Nova HD+Aura Wellness, LLC20260—
+7K253408CoolToneZimmer Medizinsysteme GmbH20260—
+7K251594truFlexSyrma Johari Medtech Limited20250—
+7K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc.20231—
+7K213741TENS & EMS DEVICE (Model: FM-B2403A)Shenzhen Jian Feng Electronic Technology Co., Ltd.20221—
+7K213835TENS & EMS DeviceShenzhen Jian Feng Electronic Technology Co., Ltd.20220—
+7K200694Perfect EMSTenscare, Ltd.20211—
+7K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Hivox Biotek, Inc.20214—
+8K243131Triathlon ProSigma Biomedical20250—
+8K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—
+8K230926Ova+ (K-OVAP-USA)Tenscare, Ltd.20230—
+8K223308Heating Tens/Ems, FT-810RHivox Biotek, Inc.20230—
+8K213091Well-Life TENS/EMS/Heating StimulatorWell-Life Healthcare Limited20220—
+8K212918Heat StimPlusFamidoc Technology Co., Ltd.20210—