510(k) Report

Devices descending from K033122

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1335025000Z Firefly SystemPrizm Medical, Inc.20140—
+1K130114Painmaster MCT PatchNewmark, Inc.20135—
+1K112415Lifecare Arm & Leg Pain Relief SystemEveryway Medical Instruments Co.,Ltd20110—
+1K102598HI-Dow-XPHi-Dow International, Inc.201178—
+1K091757Otc Tens for Arm and Leg Pain Relief, Model WL-2407Well-Life Healthcare Limited20106—
+1K090042Painmaster MCT PatchNewmark, Inc.200911—
+1K060846Therapeutic Massage CompanionEndurance Therapeutics2007151—
+2K182267PAT (Pain Alleviation Technologies)Marchan Medical, LLC20190—
+2K163393Hi-Dow Wireless TENS/EMS System (Model HD-5N)Hi-Dow International, Inc.20171—
+2K151995Painmaster MCT PatchNewmark, Inc.20160—
+2K1521282-in-1 Abdominal Muscle Training & Back Pain Relief SystemTohkai Precision Electrical Manufactory (Shenzhen) Limited20150—
+2K151034PainKARETriowave Technologies20150—
+2K151479EV-820 OTC Pain Relief TENSEveryway Medical Instruments Co.,Ltd20150—
+2K150681Gemore Otc TensGemore Technology Co, Ltd.20150—
+2K133789Dolphin Neurostim OtcAcumed Medical, Ltd.20151—
+2K142686StimPad OTCAemed, Inc.20140—
+2K133979TENSSunmas (H.K.) Trading Limited20140—
+2K131290IQ TechnologiesIq Technologies, Inc.20148—
+2K132563Pinook StimulatorPinook USA20140—
+2K130723FDES106 Mini Tens&Ems Device,FDES106 Multi-Function Mini Tens&Ems Device,FDES105 Pain…Famidoc Technology Co., Ltd.20142—
+2K133723Otc PatchWell-Life Healthcare Limited20143—
+2K122410I Rune (I-200L)Medirune Co, Ltd.20130—
+2K121719SM Tens & PMSHong Qiangxing (Shenzhen) Electronics Limited201330—
+2K122744Prospera Otc Tens Electronic Pulse MassagerProspera Corporation201355—
+2K121757HealthmateforeverHealthmate International, LLC201222—
+2K121353Mini PatchWell-Life Healthcare Limited20121—
+2K120500The Pain Pilot (a.K.a Pain Pilot)Hollywog, LLC20124—
+2K112392Hivox Biotek Inc.Hivox Biotek, Inc.201258—
+2K113037Pain-AidPdi Works, LLC201233—
+2K110068Model PM3030Omron Healthcare, Inc.201150—
+2K093999Arp Pov SportArp Manufacturing, Inc.20101—
+2K100441Xiniwave, Model XW-18International Trade Group, Inc.20101—
+3K241785StarFormer (M008-3T)Fotona D.O.O.20250—
+3K220524Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series)Well-Life Healthcare Limited20220—
+3K201354Tens & PMSHong Qiangxing (Shenzhen) Electronics Limited20201—
+3K193655MSLS6QF TENS/PMS DeviceSelf Doctor Care, LLC20200—
+3K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited20190—
+3K191181NXPRO Neuromuscular Electrical Stimulation DeviceNeux Technologies, Inc.20190—
+3K182671Medi-Direct TENS PenJkh USA, LLC20190—
+3K171092XiniWave II Model ECS322PInternational Trade Group, Inc.20170—
+3K170659IQ TechnologiesIq Technologies, Inc.20170—
+3K162392AvazziaAvazzia, Inc.20170—
+3K170145Digital TENS UnitShenzhen Eapply Technology Co., Ltd.20170—
+3K160508Electronic Pulse StimulatorBeijing Choice Electronic Technololgy Co., Ltd.20162—
+3K161537OTC TENS Device, Model PTS-IVCounter Scientific Development (Gz), Ltd.20160—
+3K160893HANAROCare ReJuM.I.Tech Co., Ltd.20162—
+3K152852ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Bayer Healthcare, LLC20152—
+3K143207Revitive IX (OTC)Actegy, Ltd.201517—
+3K141978Maxpower ReliefOmron Healthcare, Inc.201410—
+3K133929Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited201426—
+3K141260Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd.20145—
+3K140168Easystim TN28_OtcEasymed Instruments Co., Ltd.20146—
+3K140650Hivox Electric Stimulator Otc TensHivox Biotek, Inc.20142—
+3K132993Counter Otc Tens DeviceCounter Scientific Development (Gz), Ltd.201426—
+3K131956Quick Relax ProHealthcare Innovations, LLC20140—
+3K131910MPPMarc Pro20141—
+3K131933Electronic Pulse MassagerGurin Products, LLC20130—
+3K131921Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd.20136—
+3K123866TANYXMedecell Us, Inc.20131—
+3K130074Gymform Abs-a-RoundWell Brain International, Ltd.20133—
+3K131159SmartreliefChattem, Inc.201332—
+4K242815Pocket Tens (EP-300)Hivox Biotek, Inc.20240—
+4K241678TENS & EMS Stimulator (MHD-1083)Shenzhen Minghuangda Electronics Co., Ltd.20240—
+4K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+4K240292Transcutaneous Electrical Nerve Stimulator (9029SCM)Hong Kong Etech Groups Limited20240—
+4K232439Electrical Stimulator SystemGymmax Technology Shenzen Co., Ltd.20240—
+4K221992Electronic Pulse StimulatorBeijing Choice Electronic Technology Co., Ltd.20220—
+4K202653Gymform Total ABSWell Brain International, Ltd.20210—
+4K200237Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20200—
+4K191982Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220…Shenzhen Kentro Medical Electronics Co., Ltd.20202—
+4K200561StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd.20202—
+4K190783Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited20206—
+4K190673Health Expert Electronic StimulatorShenzhen Osto Technology Company Limited20191—
+4K183674Electronic Pulse StimulatorShenzhen Leading Perfection Technology Co., Ltd.20190—
+4K182136Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)Shenzhen Osto Technology Co., Ltd.20190—
+4K183103EMS Belt (Model MC0485)Dongguan Yingfeng Metal & Plastic Products Co., Ltd.20190—
+4K183288Transcutaneous Electrical Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20191—
+4K182120Maxpower ReliefOmron Healthcare, Inc.20190—
+4K172897Neck Care Therapy, Model: SYK 509BShenzhen Osto Technology Co., Ltd.20183—
+4K172837Low-frequency Multi-function physiotherapy instrumentShenzhen Osto Technology Co., Ltd.20180—
+4K172834Dual output digital therapy massagerShenzhen Osto Technology Co., Ltd.20180—
+4K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)Bayer Healthcare, LLC20180—
+4K172451Dr.MUSIC 3sSmartmedicaldevice Co., Ltd.20170—
+4K163611Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd.20172—
+4K170205Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203Shenzhen Kentro Medical Electronics Co., Ltd.20170—
+4K160323FlowKeepersDk Electronics, LLC20170—
+4K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG2017111
+4K162479Smart Pain Reliever, Model LT5019Shenzhen Dongdixin Technology Co., Ltd.20173—
+4K160255HBOTC Muscle and Nerve StimulatorHb Medical, Inc.20160—
+4K153704StriveDjo, LLC201624—
+4K160115Heat Pain ProOmron Healthcare, Inc.20168—
+4K150386Tyece OTC TENS DeviceTyece, Ltd.201524—
+4K150043Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd.20151—
+4K143430SmartTENSEasy Med Instrument Co., Ltd.20151—
+4K142055Gymform Abs & CoreWell Brain International, Ltd.20151—
+5K243165Limfa Therapy System (Limfa Therapy)Eywa Srl20250—
+5K240348Quantum Mitohormesis (QMT) (M2101)Quantumtx Pte., Ltd.20240—
+5K231368Bemer Therapy System EvoBemer Int AG20230—
+5K230443TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)Jiangxi Royall Smart Technology Co., Ltd.20230—
+5K223428Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A…Shenzhen Leqing Medical Instrument Co., Ltd.20230—