510(k) Report

Devices descending from K110068

50 later devices reach Model PM3030 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141978Maxpower ReliefOmron Healthcare, Inc.201410—
+1K1335025000Z Firefly SystemPrizm Medical, Inc.20140—
+1K140168Easystim TN28_OtcEasymed Instruments Co., Ltd.20146—
+1K132993Counter Otc Tens DeviceCounter Scientific Development (Gz), Ltd.201426—
+1K123866TANYXMedecell Us, Inc.20131—
+1K120500The Pain Pilot (a.K.a Pain Pilot)Hollywog, LLC20124—
+2K183288Transcutaneous Electrical Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20191—
+2K182120Maxpower ReliefOmron Healthcare, Inc.20190—
+2K172451Dr.MUSIC 3sSmartmedicaldevice Co., Ltd.20170—
+2K161537OTC TENS Device, Model PTS-IVCounter Scientific Development (Gz), Ltd.20160—
+2K160115Heat Pain ProOmron Healthcare, Inc.20168—
+2K152852ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Bayer Healthcare, LLC20152—
+2K150386Tyece OTC TENS DeviceTyece, Ltd.201524—
+2K150043Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd.20151—
+2K143430SmartTENSEasy Med Instrument Co., Ltd.20151—
+3K222867AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd.20220—
+3K200237Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20200—
+3K190783Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited20206—
+3K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited20190—
+3K181992Heat Pain ProOmron Healthcare, Inc.20180—
+3K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)Bayer Healthcare, LLC20180—
+3K171803HIVOX OTC Electrical StimulatorHivox Biotek, Inc.201721—
+3K170205Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203Shenzhen Kentro Medical Electronics Co., Ltd.20170—
+3K170145Digital TENS UnitShenzhen Eapply Technology Co., Ltd.20170—
+4K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.20260—
+4K242460Progenix Select StimProgenix, LLC20250—
+4K242815Pocket Tens (EP-300)Hivox Biotek, Inc.20240—
+4K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+4K232439Electrical Stimulator SystemGymmax Technology Shenzen Co., Ltd.20240—
+4K223428Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A…Shenzhen Leqing Medical Instrument Co., Ltd.20230—
+4K221251Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)Guangzhou Huakai Electronic Technology Co., Ltd.20220—
+4K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited20211—
+4K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+4K200558Smart Neck StimulatorGuandong Skg Intelligent Technology Co., Ltd.20210—
+4K210756Neck Care Therapy, Model: AST-905A, AST-905D, AST-905HShenzhen Osto Technology Company Limited20211—
+4K202866TENS & EMS DeviceShenzhen Jian Feng Electronic Technology Co., Ltd.20213—
+4K183674Electronic Pulse StimulatorShenzhen Leading Perfection Technology Co., Ltd.20190—
+4K183103EMS Belt (Model MC0485)Dongguan Yingfeng Metal & Plastic Products Co., Ltd.20190—
+4K190347HIVOX OTC Electrical StimulatorHivox Biotek, Inc.20198—
+4K181728Muscle TrainerShenzhen Kentro Medical Electronics Co., Ltd.20180—
+5K221092Transcutaneous Electrical Nerve Stimulator Model: ST-304Shenzhen Future Electronic Co., Ltd.20220—
+5K213741TENS & EMS DEVICE (Model: FM-B2403A)Shenzhen Jian Feng Electronic Technology Co., Ltd.20221—
+5K213835TENS & EMS DeviceShenzhen Jian Feng Electronic Technology Co., Ltd.20220—
+5K200694Perfect EMSTenscare, Ltd.20211—
+5K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Hivox Biotek, Inc.20214—
+6K243131Triathlon ProSigma Biomedical20250—
+6K230926Ova+ (K-OVAP-USA)Tenscare, Ltd.20230—
+6K223308Heating Tens/Ems, FT-810RHivox Biotek, Inc.20230—
+6K213091Well-Life TENS/EMS/Heating StimulatorWell-Life Healthcare Limited20220—
+6K212918Heat StimPlusFamidoc Technology Co., Ltd.20210—