510(k) Report

Devices descending from K940301

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080950Stiwell MED4Otto Bock, Austria GmbH200934—
+1K011880Compex SportCompex S.A.2002195—
+2K243828Cionic Neural Sleeve (NS-200)Cionic, Inc.20250—
+2K232786Stimulation System (PA series, PR series, S series and Q series)Edan Instruments, Inc.20240—
+2K230701Stim2GoPAJUNK GmbH Medizintechnologie20230—
+2K210002Stella BioEgzotech Sp. Z O. O.20211—
+2K202648Biofeedback Nerve and Muscle StimulatorShenzhen Konmed Technology Co., Ltd.20202—
+2K200088g.Estim FESG.Tec Medical Engineering GmbH20200—
+2K201290Medline DeNovo 4Pro Electrical Stimulation DeviceMedline Industries, Inc.20202—
+2K133225E-Fit EF-1280 Ems MachineFit-Pro Kft, Ltd.201419—
+2K122393TG-Body MI&Body S-TrainerMiga Medical Co., Ltd.20130—
+2K123158Ion Magnum GeniusIon Genius, Inc.20137—
+2K111476Contour Technology Muscle StimulatorContour Technology20124—
+2K110179IncontrolIncontrol Medical, LLC201221—
+2K102598HI-Dow-XPHi-Dow International, Inc.201178—
+2K093999Arp Pov SportArp Manufacturing, Inc.20101—
+2K081998H-Wave SportElectronic Waveform Laboratory, Inc.20092—
+2K083140Compex Sport PlusChattanooga Group200939—
+2K071666Slendertone Enervive, Model 561Bio-Medical Research Corp.20084—
+2K060846Therapeutic Massage CompanionEndurance Therapeutics2007151—
+2K061632Globus Premium Muscle StimulatorDomino S.R.L.200740—
+2K031611P4-FitnessValmed Corp.20045—
+3K243079NeuroTrac® MyoPlus Pro (MYO120U)Verity Medical, Ltd.20250—
+3K241488TrainFES AdvanceTrainfes20250—
+3K222201Biological Feedback and Stimulation SystemMedlander Medical Technology, Inc.20220—
+3K220161Biofeedback Nerve and Muscle StimulatorShenzhen Konmed Technology Co., Ltd.20220—
+3K213043Levator Elite (Model LE9011)Shenzhen Dongdixin Technology Co., Ltd.20220—
+3K202148E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)Fit-Pro, Ltd.20211—
+3K191181NXPRO Neuromuscular Electrical Stimulation DeviceNeux Technologies, Inc.20190—
+3K182519Miha Bodytec IIMiha Bodytec GmbH20193—
+3K181419Flix-EmsCasgarum Investment, S.L.20190—
+3K190038Xbody Newave USAXbody Hungary Kft.20194—
+3K182440Body SystemA-1 Engineering20195—
+3K181955WiEMSproMedical Cables S.L.20193—
+3K181199Katalyst Mark 1 Muscle Stimulation System Model 2Katalyst, Inc.20181—
+3K163288Pelvifine Pelvic Muscle TrainerShenzhen Konmed Technology Co., Ltd.20180—
+3K171035Katalyst Mark 1 Muscle Stimulation SystemKatalyst, Inc.20170—
+3K163393Hi-Dow Wireless TENS/EMS System (Model HD-5N)Hi-Dow International, Inc.20171—
+3K170918Compex Sport EliteDjo, LLC20174—
+3K162479Smart Pain Reliever, Model LT5019Shenzhen Dongdixin Technology Co., Ltd.20173—
+3K152420AK Body Toning DeviceAk Beauty Enterprises, LLC20160—
+3K1521282-in-1 Abdominal Muscle Training & Back Pain Relief SystemTohkai Precision Electrical Manufactory (Shenzhen) Limited20150—
+3K150078PowerDot (R) PD-01 Muscle Stimulator (with PowerDot (R) Mobile Application)Smartmissimo Technologies Pte, Ltd.20152—
+3K142369Urinary Incontinence SystemGuangzhou Finecure Medical Equipment Co.,Ltd20150—
+3K141919Veinoplus Sport Neuromuscular StimulatorAd Rem Technology Sarl20150—
+3K142055Gymform Abs & CoreWell Brain International, Ltd.20151—
+3K143551Compex Wireless USADjo, LLC201520—
+3K150183ApexMIncontrol Medical, LLC20153—
+3K150180InToneIncontrol Medical, LLC20150—
+3K142686StimPad OTCAemed, Inc.20140—
+3K141158APEXIncontrol Medical, LLC20149—
+3K133979TENSSunmas (H.K.) Trading Limited20140—
+3K131290IQ TechnologiesIq Technologies, Inc.20148—
+3K134001FireflyFirstkind Limited20141—
+3K132179ArasysIon Genius, Inc.20140—
+3K132563Pinook StimulatorPinook USA20140—
+3K134020IntonemvIncontrol Medical, LLC201410—
+3K130723FDES106 Mini Tens&Ems Device,FDES106 Multi-Function Mini Tens&Ems Device,FDES105 Pain…Famidoc Technology Co., Ltd.20142—
+3K131910MPPMarc Pro20141—
+3K133826IntonemvIncontrol Medical, LLC20140—
+3K122410I Rune (I-200L)Medirune Co, Ltd.20130—
+3K130074Gymform Abs-a-RoundWell Brain International, Ltd.20133—
+3K121719SM Tens & PMSHong Qiangxing (Shenzhen) Electronics Limited201330—
+3K122744Prospera Otc Tens Electronic Pulse MassagerProspera Corporation201355—
+3K121757HealthmateforeverHealthmate International, LLC201222—
+3K120500The Pain Pilot (a.K.a Pain Pilot)Hollywog, LLC20124—
+3K112392Hivox Biotek Inc.Hivox Biotek, Inc.201258—
+3K113037Pain-AidPdi Works, LLC201233—
+3K110068Model PM3030Omron Healthcare, Inc.201150—
+3K110057Mini MasseuseMj Specialty Retail20110—
+3K102926Gemore Muscle Conditioner;Gemore Technology Co, Ltd.20110—
+3K102786Well-Life Otc Ems SystemWell-Life Healthcare Limited20110—
+3K100441Xiniwave, Model XW-18International Trade Group, Inc.20101—
+3K091757Otc Tens for Arm and Leg Pain Relief, Model WL-2407Well-Life Healthcare Limited20106—
+3K083164System-Arms, Models 390, X60Bio-Medical Research, Ltd.20080—
+4K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+4K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.20250—
+4K241785StarFormer (M008-3T)Fotona D.O.O.20250—
+4K230261Gnesis EMS PlusCreative Fitness Developments S.L.20230—
+4K221200XBody Go USA, XBody Pro USAXbody Hungary Kft.20233—
+4K211298WiEMSproMedical Cables S.L.20220—
+4K212413I-MotionI-Motion Group Global Iberica S.L.20221—
+4K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+4K200545Legend Pro DMAPollogen, Ltd.20211—
+4K201975miha bodytec IIMiha Bodytec GmbH20212—
+4K202653Gymform Total ABSWell Brain International, Ltd.20210—
+4K201354Tens & PMSHong Qiangxing (Shenzhen) Electronics Limited20201—
+4K201653Compex Sport Elite 3.0Djo, LLC20202—
+4K182020Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd.20200—
+4K193655MSLS6QF TENS/PMS DeviceSelf Doctor Care, LLC20200—
+4K201131firefly T-2Firstkind Limited20200—
+4K192161FastFit EMS SystemFast Fit, LLC20200—
+4K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited20190—
+4K182794BionicGym Powered Muscle StimulatorMedical Currents, Ltd.20190—
+4K182022ApexMVIncontrol Medical, LLC20191—
+4K181497HPM-6000UFBTL Industries, Inc.20186—
+4K181728Muscle TrainerShenzhen Kentro Medical Electronics Co., Ltd.20180—
+4K173462Wireless Pain Relieve Device Model: LT5018CShenzhen Dongdixin Technology Co., Ltd.20172—
+4K171092XiniWave II Model ECS322PInternational Trade Group, Inc.20170—
+4K170903Compex Wireless USADjo, LLC201710—