510(k) Report

Devices descending from K940301

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K210756Neck Care Therapy, Model: AST-905A, AST-905D, AST-905HShenzhen Osto Technology Company Limited20211—
+6K203710Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG20214—
+6K200177Low-frequency Multi-function physiotherapy instrumentShenzhen Kentro Medical Electronics Co., Ltd.20210—
+6K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG20215—
+6K182203JKH Stimulator PlusJkh USA, LLC20197—
+6K181992Heat Pain ProOmron Healthcare, Inc.20180—
+6K171803HIVOX OTC Electrical StimulatorHivox Biotek, Inc.201721—
+7K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.20260—
+7K252767actiTENS miniSublimed20260—
+7K250896Aura WaveAura Wellness, LLC20251—
+7K242460Progenix Select StimProgenix, LLC20250—
+7K240234BTL-899MSBTL Industries, Inc.20242—
+7K220938Nova HD+Aura Wellness, LLC20231—
+7K202866TENS & EMS DeviceShenzhen Jian Feng Electronic Technology Co., Ltd.20213—
+7K202159actiTENSSublimed20201—
+7K191151JKH Stimulator PlusJkh USA, LLC20194—
+7K190347HIVOX OTC Electrical StimulatorHivox Biotek, Inc.20198—
+8K262788Nova HD+Aura Wellness, LLC20260—
+8K253408CoolToneZimmer Medizinsysteme GmbH20260—
+8K251594truFlexSyrma Johari Medtech Limited20250—
+8K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc.20231—
+8K213741TENS & EMS DEVICE (Model: FM-B2403A)Shenzhen Jian Feng Electronic Technology Co., Ltd.20221—
+8K213835TENS & EMS DeviceShenzhen Jian Feng Electronic Technology Co., Ltd.20220—
+8K200694Perfect EMSTenscare, Ltd.20211—
+8K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Hivox Biotek, Inc.20214—
+9K243131Triathlon ProSigma Biomedical20250—
+9K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—
+9K230926Ova+ (K-OVAP-USA)Tenscare, Ltd.20230—
+9K223308Heating Tens/Ems, FT-810RHivox Biotek, Inc.20230—
+9K213091Well-Life TENS/EMS/Heating StimulatorWell-Life Healthcare Limited20220—
+9K212918Heat StimPlusFamidoc Technology Co., Ltd.20210—