510(k) Report

Devices descending from K031077

73 later devices reach Vectra Epr System and Intelect Epr System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210572Neurodyn V2.0, Neurodyn Aussie V2.0Ibramed Equipamentos Medicos20210—
+1K150353BTL-4000BTL Industries, Inc.20150—
+1K131629Neurodyn Multiwave, Aussie SportIbramed Equipamentos Medicos20131—
+1K121369Neurodyn Ruby Muscle Stimulator, Neurodyn Aussie Muscle StimulatorIbramed Equipamentos Medicos20125—
+1K121059Soleoline, Soleo Stim, Soleo Sono, Soleo SonostimZimmer Medizinsystems GmbH20124—
+1K113017Sys*Stim 240Mettler Electronics Corp.20129—
+1K071431Globus Genesy 1100 StimulatorDomino S.R.L.200729—
+1K071137Sonicator Plus 940, Model ME940Mettler Electronics Corp.200719—
+1K063135Sonic-StimNaimco, Inc.20070—
+2K223802accufitMettler Electronics Corporation20235—
+2K213655HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)Hilltek, LLC20231—
+2K171978Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10Shenzhen Dongdixin Technology Co., Ltd.20172—
+2K161628JAS Pulse (TM) Ultrasonic TherapyBonutti Research, Inc.20163—
+2K131923Neurodyn Portable Tens Nfes, Neurodyn Portable TensTechlink International20140—
+2K131917Neurodyn Compact, Neurodyn IIIbramed Equipamentos Medicos20141—
+2K123177Stimlase 2000 Low Level Laser Therapy SystemLaserstim, Inc.20130—
+2K111482Sonicator Plus 920Mettler Electronics Corp.20111—
+2K093138MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003Shenzhen Dongdixin Technology Co., Ltd.2010151
+2K092627CT2011 Sonicstimu Pain Relief DeviceShenzhen Dongdixin Technology Co., Ltd.20100—
+2K090632Compex RehabChattanooga Group200928—
+3K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali Nezakati20260—
+3K241099Plasonic (Plasonic)Hironic Co., Ltd.20242—
+3K233926accufitMettler Electronics Corporation20244—
+3K231440Combo Electrotherapy DeviceShenzhen Roundwhale Technology Co., Ltd.20230—
+3K223797Neuro20 Pro SystemNeuro20 Technologies20230—
+3K213197MyOnyx SystemThought Technology, Ltd.20220—
+3K201975miha bodytec IIMiha Bodytec GmbH20212—
+3K181645StimaWELL 120MTRSPierenkemper GmbH20200—
+3K182108Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd.20190—
+3K124016Empi PhoenixDjo, LLC201325—
+3K113010FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens StimulatorFamidoc Technology Co., Ltd.20128—
+3K120054Ultima NeoPain Management Technologies20122—
+4K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd.20260—
+4K251334New Doublo 2.0Hironic Co., Ltd.20250—
+4K251594truFlexSyrma Johari Medtech Limited20250—
+4K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.20241—
+4K241685SofWave SystemSofwave Medical, Ltd.20242—
+4K221498Miha Bodytec IIMiha Bodytec GmbH20220—
+4K183074TENS and EMS Stimulator, TENS StimulatorAstek Technology, Ltd.20200—
+4K181688R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS StimulatorShenzhen Roundwhale Technology Co., Ltd.20186—
+4K153704StriveDjo, LLC201624—
+5K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC20250—
+5K250146SofWave SystemSofwave Medical, Ltd.20251—
+5K210021Axon TherapyNeuralace Medical, Inc.20215—
+5K182203JKH Stimulator PlusJkh USA, LLC20197—
+5K170918Compex Sport EliteDjo, LLC20174—
+5K170903Compex Wireless USADjo, LLC201710—
+6K252767actiTENS miniSublimed20260—
+6K251746Pure ImpactSofwave Medical, Ltd.20250—
+6K233364Axon TherapyNeuralace Medical, Inc.20241—
+6K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100…Tonica Elektronik A/S20233—
+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—
+7K253636Zionic Pro Max (EMS)Termosalud S.L.20260—
+7K252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.20250—
+7K250309BTL-199BTL Industries, Inc.20250—
+7K250286Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2…The Magstim Company Limited20250—
+7K241785StarFormer (M008-3T)Fotona D.O.O.20250—
+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—
+7K211298WiEMSproMedical Cables S.L.20220—
+7K212413I-MotionI-Motion Group Global Iberica S.L.20221—
+7K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+8K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—