510(k) Report

Devices descending from K150386

24 later devices reach Tyece OTC TENS Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171803HIVOX OTC Electrical StimulatorHivox Biotek, Inc.201721—
+1K170205Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203Shenzhen Kentro Medical Electronics Co., Ltd.20170—
+1K170145Digital TENS UnitShenzhen Eapply Technology Co., Ltd.20170—
+2K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.20260—
+2K242460Progenix Select StimProgenix, LLC20250—
+2K242815Pocket Tens (EP-300)Hivox Biotek, Inc.20240—
+2K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+2K232439Electrical Stimulator SystemGymmax Technology Shenzen Co., Ltd.20240—
+2K200558Smart Neck StimulatorGuandong Skg Intelligent Technology Co., Ltd.20210—
+2K202866TENS & EMS DeviceShenzhen Jian Feng Electronic Technology Co., Ltd.20213—
+2K183674Electronic Pulse StimulatorShenzhen Leading Perfection Technology Co., Ltd.20190—
+2K183103EMS Belt (Model MC0485)Dongguan Yingfeng Metal & Plastic Products Co., Ltd.20190—
+2K190347HIVOX OTC Electrical StimulatorHivox Biotek, Inc.20198—
+2K181728Muscle TrainerShenzhen Kentro Medical Electronics Co., Ltd.20180—
+3K213741TENS & EMS DEVICE (Model: FM-B2403A)Shenzhen Jian Feng Electronic Technology Co., Ltd.20221—
+3K213835TENS & EMS DeviceShenzhen Jian Feng Electronic Technology Co., Ltd.20220—
+3K200694Perfect EMSTenscare, Ltd.20211—
+3K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Hivox Biotek, Inc.20214—
+4K243131Triathlon ProSigma Biomedical20250—
+4K230926Ova+ (K-OVAP-USA)Tenscare, Ltd.20230—
+4K223308Heating Tens/Ems, FT-810RHivox Biotek, Inc.20230—
+4K221251Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)Guangzhou Huakai Electronic Technology Co., Ltd.20220—
+4K213091Well-Life TENS/EMS/Heating StimulatorWell-Life Healthcare Limited20220—
+4K212918Heat StimPlusFamidoc Technology Co., Ltd.20210—