510(k) Report

Devices descending from K926510

77 later devices reach Staodyn Ems+2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050046Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110SCompex Technologies, Inc.200556—
+1K024258Neurotech KneehabBio-Medical Research, Ltd.200515—
+1K041063Smartwave MS 2000Newwave Medical, LLC20041—
+1K973223Stellar Model HS-04Stellar Medical Corp.19981—
+2K162987FA100 SCCD (Sequential Continuous Contraction Device)Flowaid Medical Technologies, Corp20175—
+2K123354Revitive IXActegy, Ltd.201319—
+2K121305Sterling Medical Impulse 3 StimulatorArmstrong Industries, Inc. Dha Mediquip Int. Dha S20120—
+2K093324Empi ContinuumEmpi201026—
+2K090532T.E.a.R. TECH3Vision Quest Industries, Inc.20092—
+2K083105Kneehab XP Conductive Garment, Type 411Bio-Medical Research, Ltd.200914—
+2K990697RS-4V Muscle StimulatorRs Medical19990—
+3K183692Avid IF2Vision Quest Industries Inc./Dba VQ Orthocare20191—
+3K180082geko T-2 and geko Plus R-2Firstkind, Ltd.20184—
+3K171071StimSox (TM) SystemStimmed, LLC20170—
+3K143207Revitive IX (OTC)Actegy, Ltd.201517—
+3K124016Empi PhoenixDjo, LLC201325—
+3K123642Muscle Stimulation SystemNiveus Medical, Inc.20131—
+3K110350Kneehab XPBio-Medical Research, Ltd.20119—
+3K092791Kneehab XP Controller, Model 411Bio-Medical Research, Ltd.20090—
+3K092793Modification to:Kneehab XP Conductive Garment, Model 411Bio-Medical Research, Ltd.20090—
+4K202490Avid CT2Vision Quest Industries Inc./Dba VQ Orthocare20200—
+4K193045geko™ W-2Firstkind Limited20201—
+4K183103EMS Belt (Model MC0485)Dongguan Yingfeng Metal & Plastic Products Co., Ltd.20190—
+4K191113geko T-2 and geko T-3 Neuromuscular StimulatorsFirstkind Limited20190—
+4K191587L360 Thigh SystemBioness, Inc.20190—
+4K181059geko T-3 Neuromuscular StimulatorFirstkind Limited20181—
+4K163611Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd.20172—
+4K160323FlowKeepersDk Electronics, LLC20170—
+4K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG2017111
+4K153704StriveDjo, LLC201624—
+4K150742Muscle Stimulation System 110Niveus Medical, Inc.20150—
+4K150413QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorCymedica Orthopedics, Inc.20157—
+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—
+5K212832TimeWaver FrequencyTimewaver Production GmbH20211—
+5K212762geko W-2Firstkind Limited20210—
+5K203710Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG20214—
+5K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG20215—
+5K200237Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd.20200—
+5K182203JKH Stimulator PlusJkh USA, LLC20197—
+5K170918Compex Sport EliteDjo, LLC20174—
+5K170903Compex Wireless USADjo, LLC201710—
+5K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc.20164—
+6K252767actiTENS miniSublimed20260—
+6K250896Aura WaveAura Wellness, LLC20251—
+6K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+6K240234BTL-899MSBTL Industries, Inc.20242—
+6K220938Nova HD+Aura Wellness, LLC20231—
+6K210674Shoulder PacemakerNcs Lab Srl20211—
+6K210604Intellihab SystemCymedica Orthopedics, Inc.20211—
+6K202159actiTENSSublimed20201—
+6K201653Compex Sport Elite 3.0Djo, LLC20202—
+6K201845Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)Guangzhou Longest Science & Technology Co., Ltd.20200—
+6K182020Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd.20200—
+6K190966Katalyst Training SystemKatalyst, Inc.20203—
+6K191151JKH Stimulator PlusJkh USA, LLC20194—
+6K181419Flix-EmsCasgarum Investment, S.L.20190—
+6K181955WiEMSproMedical Cables S.L.20193—
+7K262788Nova HD+Aura Wellness, LLC20260—
+7K253636Zionic Pro Max (EMS)Termosalud S.L.20260—
+7K253408CoolToneZimmer Medizinsysteme GmbH20260—
+7K252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.20250—
+7K251594truFlexSyrma Johari Medtech Limited20250—
+7K233770Pepper EMS Training SystemPepper Interactive, Inc.20250—
+7K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+7K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc.20231—
+7K230261Gnesis EMS PlusCreative Fitness Developments S.L.20230—
+7K222386VisionbodyVb Technologies AG20230—
+7K220994Shoulder PacemakerTMNcs Lab Srl20220—
+7K221498Miha Bodytec IIMiha Bodytec GmbH20220—
+7K211298WiEMSproMedical Cables S.L.20220—
+7K212413I-MotionI-Motion Group Global Iberica S.L.20221—
+7K220738Motive Knee WrapCymedica Orthopedics, Inc.20220—
+7K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+8K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—