510(k) Report

Devices descending from K130802

45 later devices reach Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251958VEINOPLUS BackDynapulse Medical20250—
+1K232439Electrical Stimulator SystemGymmax Technology Shenzen Co., Ltd.20240—
+1K220573NoodlePourang Bral, Dds, LLC20220—
+1K200838Tyece OTC TENS ModelTyece Limited20200—
+1K180956Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator…Shenzhen Roundwhale Technology Co., Ltd.20180—
+1K171803HIVOX OTC Electrical StimulatorHivox Biotek, Inc.201721—
+1K151035PulseReliefPhilips Consumer Lifestyle201520—
+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—
+2K200558Smart Neck StimulatorGuandong Skg Intelligent Technology Co., Ltd.20210—
+2K202866TENS & EMS DeviceShenzhen Jian Feng Electronic Technology Co., Ltd.20213—
+2K192733RelieforMe TENS/EMS Device Model UPK-GE01Umeheal, Ltd.20191—
+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—
+2K172451Dr.MUSIC 3sSmartmedicaldevice Co., Ltd.20170—
+2K172079AvailOmron Healthcare, Inc.20175—
+2K163153LiviaLifecare, Ltd.20174—
+2K162479Smart Pain Reliever, Model LT5019Shenzhen Dongdixin Technology Co., Ltd.20173—
+2K160052CUR Model 1Thimble Bioelectronics, Inc.20161—
+3K233784ENSO (Model 2)Hinge Health, Inc.20240—
+3K220738Motive Knee WrapCymedica Orthopedics, Inc.20220—
+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—
+3K183110LIVIALifecare, Ltd.20203—
+3K191075HealyTimewaver Production GmbH20190—
+3K183215Focus TENS Therapy, Model PM710-M/-LOmron Healthcare, Inc.20191—
+3K182120Maxpower ReliefOmron Healthcare, Inc.20190—
+3K181992Heat Pain ProOmron Healthcare, Inc.20180—
+3K173462Wireless Pain Relieve Device Model: LT5018CShenzhen Dongdixin Technology Co., Ltd.20172—
+4K243131Triathlon ProSigma Biomedical20250—
+4K233054Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual…Well-Life Healthcare Limited20240—
+4K230926Ova+ (K-OVAP-USA)Tenscare, Ltd.20230—
+4K223308Heating Tens/Ems, FT-810RHivox Biotek, Inc.20230—
+4K220997Wireless TENS/EMS, Bruno, AelaZmi Elecronics, Ltd.20220—
+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—
+4K181102ThermaCare Quick Therapy TENSPfizer, Inc.20180—
+4K180331Wireless Pain Relieve DeviceShenzhen Dongdixin Technology Co., Ltd.20180—