510(k) Report

Devices descending from K033122

158 later devices reach 5000Z System (Otc) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+5K181728Muscle TrainerShenzhen Kentro Medical Electronics Co., Ltd.20180—
+5K173462Wireless Pain Relieve Device Model: LT5018CShenzhen Dongdixin Technology Co., Ltd.20172—
+5K171803HIVOX OTC Electrical StimulatorHivox Biotek, Inc.201721—
+5K170918Compex Sport EliteDjo, LLC20174—
+5K170903Compex Wireless USADjo, LLC201710—
+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—
+6K201653Compex Sport Elite 3.0Djo, LLC20202—
+6K201845Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)Guangzhou Longest Science & Technology Co., Ltd.20200—
+6K182020Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd.20200—
+6K190966Katalyst Training SystemKatalyst, Inc.20203—
+6K191151JKH Stimulator PlusJkh USA, LLC20194—
+6K181419Flix-EmsCasgarum Investment, S.L.20190—
+6K190347HIVOX OTC Electrical StimulatorHivox Biotek, Inc.20198—
+6K181955WiEMSproMedical Cables S.L.20193—
+6K181102ThermaCare Quick Therapy TENSPfizer, Inc.20180—
+6K180331Wireless Pain Relieve DeviceShenzhen Dongdixin Technology Co., Ltd.20180—
+7K262788Nova HD+Aura Wellness, LLC20260—
+7K253636Zionic Pro Max (EMS)Termosalud S.L.20260—
+7K253408CoolToneZimmer Medizinsysteme GmbH20260—
+7K252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.20250—
+7K251594truFlexSyrma Johari Medtech Limited20250—
+7K233770Pepper EMS Training SystemPepper Interactive, Inc.20250—
+7K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc.20231—
+7K230261Gnesis EMS PlusCreative Fitness Developments S.L.20230—
+7K222386VisionbodyVb Technologies AG20230—
+7K221498Miha Bodytec IIMiha Bodytec GmbH20220—
+7K211298WiEMSproMedical Cables S.L.20220—
+7K212413I-MotionI-Motion Group Global Iberica S.L.20221—
+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—