510(k) Report

Devices descending from K061632

40 later devices reach Globus Premium Muscle Stimulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083140Compex Sport PlusChattanooga Group200939—
+2K181199Katalyst Mark 1 Muscle Stimulation System Model 2Katalyst, Inc.20181—
+2K171035Katalyst Mark 1 Muscle Stimulation SystemKatalyst, Inc.20170—
+2K170918Compex Sport EliteDjo, LLC20174—
+2K162479Smart Pain Reliever, Model LT5019Shenzhen Dongdixin Technology Co., Ltd.20173—
+2K152420AK Body Toning DeviceAk Beauty Enterprises, LLC20160—
+2K150078PowerDot (R) PD-01 Muscle Stimulator (with PowerDot (R) Mobile Application)Smartmissimo Technologies Pte, Ltd.20152—
+2K141919Veinoplus Sport Neuromuscular StimulatorAd Rem Technology Sarl20150—
+2K143551Compex Wireless USADjo, LLC201520—
+2K134001FireflyFirstkind Limited20141—
+3K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.20250—
+3K201653Compex Sport Elite 3.0Djo, LLC20202—
+3K182020Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd.20200—
+3K201131firefly T-2Firstkind Limited20200—
+3K192161FastFit EMS SystemFast Fit, LLC20200—
+3K182794BionicGym Powered Muscle StimulatorMedical Currents, Ltd.20190—
+3K182440Body SystemA-1 Engineering20195—
+3K173462Wireless Pain Relieve Device Model: LT5018CShenzhen Dongdixin Technology Co., Ltd.20172—
+3K170903Compex Wireless USADjo, LLC201710—
+3K151903Slendertone connect AbsBio-Medical Research, Ltd.20151—
+4K253636Zionic Pro Max (EMS)Termosalud S.L.20260—
+4K252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.20250—
+4K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+4K200545Legend Pro DMAPollogen, Ltd.20211—
+4K201845Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)Guangzhou Longest Science & Technology Co., Ltd.20200—
+4K190966Katalyst Training SystemKatalyst, Inc.20203—
+4K181419Flix-EmsCasgarum Investment, S.L.20190—
+4K181955WiEMSproMedical Cables S.L.20193—
+4K181102ThermaCare Quick Therapy TENSPfizer, Inc.20180—
+4K180331Wireless Pain Relieve DeviceShenzhen Dongdixin Technology Co., Ltd.20180—
+4K161974SLENDERTONE® Connect Abs, Type 570Bio-Medical Research, Ltd.20160—
+5K233770Pepper EMS Training SystemPepper Interactive, Inc.20250—
+5K233470Deka LilyEl.En S.P.A.20230—
+5K230261Gnesis EMS PlusCreative Fitness Developments S.L.20230—
+5K222386VisionbodyVb Technologies AG20230—
+5K221498Miha Bodytec IIMiha Bodytec GmbH20220—
+5K211298WiEMSproMedical Cables S.L.20220—
+5K212413I-MotionI-Motion Group Global Iberica S.L.20221—
+5K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+6K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—