510(k) Report

Devices descending from K951951

81 later devices reach Focus Model 795 Unit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102115Odfs PaceOdstock Medical, Ltd.201116—
+1K050991The Odfs Dropped Foot StimulatorDepartment of Medical Physics and Biomedical Eng.200520—
+1K042912INTERX5000Neuro Resource Group, Inc.2005101
+1K041575Fenzian Treatment SystemEumedic Limited200412—
+1K013768Powered Muscle StimulatorTheratech, Inc.20020—
+1K021100300 PV Complete Electrotherapy SystemEmpi200248—
+2K171396ODFS Pace XLOdstock Medical, Ltd.20180—
+2K141812Mygait Stimulation SystemOtto Bock Healthcare Products GmbH20151—
+2K140467Flex-MT +Emsi20140—
+2K131513Scenar (Scelap, Enisar, Ipens) Cutaneous Electrode FamilyRitm Okb Zao20140—
+2K131923Neurodyn Portable Tens Nfes, Neurodyn Portable TensTechlink International20140—
+2K133779CP Relief WandMid-America Medical Innovations, LLC20141—
+2K131917Neurodyn Compact, Neurodyn IIIbramed Equipamentos Medicos20141—
+2K131629Neurodyn Multiwave, Aussie SportIbramed Equipamentos Medicos20131—
+2K123972Walkaide SystemInnovative Neurotronics, Inc.201314—
+2K110350Kneehab XPBio-Medical Research, Ltd.20119—
+2K092117Scenar, Model 10Ritm Okb Zao20101—
+2K093324Empi ContinuumEmpi201026—
+2K070217Interx 1000/Derma 200 Stimulator for Cosmetic UseNeuro Resource Group, Inc.20081—
+2K071878Delta Scanner, Delta Scanner Pro, DS Spine Pro, DS Sports Pro and DS RehabMed-Lectric Corporation20070—
+2K062616Wellnesspro 2010Intelsource Group, Inc.20070—
+2K062641Body-Stim, Biomodulator, Best-Rsi, Best Pro, Model Best-AV1Avazzia, Inc.200723
+2K053468NESS L300Ness-Neuromuscular Electrical Stimulation Systems200617—
+2K053626INTERX500 Flexible Array ElectrodeNeuro Resource Group, Inc.20061—
+2K041920Infinity Plus Electrotherapy SystemEmpi20050—
+2K042057Infinity Electrotherapy SystemEmpi20040—
+2K023050Reliant BTL 5000 Puls Electrical Stimulation System, Reliant BTL 5000 Sono Ultrasound…Reliant Technologies, Inc.20030—
+3K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC20250—
+3K202110MStim Drop Model: LGT-233Guangzhou Longest Science & Technology Co., Ltd.20210—
+3K210572Neurodyn V2.0, Neurodyn Aussie V2.0Ibramed Equipamentos Medicos20210—
+3K181645StimaWELL 120MTRSPierenkemper GmbH20200—
+3K191587L360 Thigh SystemBioness, Inc.20190—
+3K162718Foot Drop System (Model XFT-2001D)Shenzhen Xft Medical Limited20171—
+3K150413QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorCymedica Orthopedics, Inc.20157—
+3K140886Walkaide SystemInnovative Neurotronics, Inc.201410—
+3K123099Best-AV2 Pro-Sport (tm)Avazzia, Inc.20140—
+3K124016Empi PhoenixDjo, LLC201325—
+3K102494The Buzz Facial Toning SystemDaka International, Ltd.20110—
+3K080219Modification to:Ness L300Ness-Neuromuscular Electrical Stimulation Systems200816—
+4K212832TimeWaver FrequencyTimewaver Production GmbH20211—
+4K193276Nerve and Muscle StimulatorShenzhen Xft Medical Limited20200—
+4K162407L300 Go SystemBioness, Inc.20179—
+4K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc.20164—
+4K153704StriveDjo, LLC201624—
+4K103343L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left)Bioness, Inc.201115—
+5K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+5K210674Shoulder PacemakerNcs Lab Srl20211—
+5K210604Intellihab SystemCymedica Orthopedics, Inc.20211—
+5K182203JKH Stimulator PlusJkh USA, LLC20197—
+5K173682L300 Go SystemBioness, Inc.20187—
+5K170918Compex Sport EliteDjo, LLC20174—
+5K170903Compex Wireless USADjo, LLC201710—
+6K252767actiTENS miniSublimed20260—
+6K230997EvoWalk 1.0 SystemEvolution Devices, Inc.20230—
+6K220994Shoulder PacemakerTMNcs Lab Srl20220—
+6K220738Motive Knee WrapCymedica Orthopedics, Inc.20220—
+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—
+6K190285L300 Go SystemBioness, Inc.20195—
+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—
+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—
+7K221498Miha Bodytec IIMiha Bodytec GmbH20220—
+7K211298WiEMSproMedical Cables S.L.20220—
+7K212413I-MotionI-Motion Group Global Iberica S.L.20221—
+7K213622Cionic Neural Sleeve NS-100Cionic20222—
+7K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+7K200262L100 Go SystemBioness, Inc.20200—
+8K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—
+8K221823Cionic Neural Sleeve NS-100Cionic20221—
+9K243828Cionic Neural Sleeve (NS-200)Cionic, Inc.20250—