510(k) Report

Devices descending from K000114

55 later devices reach RS-4M+Muscle Stimulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032652RS-4I Muscle Stimulator FamilyRs Medical200341
+1K021100300 PV Complete Electrotherapy SystemEmpi200248—
+1K021763RS2MI Muscle Stimulator FamilyRs Medical20020—
+2K141812Mygait Stimulation SystemOtto Bock Healthcare Products GmbH20151—
+2K140467Flex-MT +Emsi20140—
+2K131923Neurodyn Portable Tens Nfes, Neurodyn Portable TensTechlink International20140—
+2K131917Neurodyn Compact, Neurodyn IIIbramed Equipamentos Medicos20141—
+2K131629Neurodyn Multiwave, Aussie SportIbramed Equipamentos Medicos20131—
+2K112348RS-4I Muscle StimulatorRs Medical20121—
+2K110350Kneehab XPBio-Medical Research, Ltd.20119—
+2K093324Empi ContinuumEmpi201026—
+2K062325RS-4I Muscle Stimulator FamilyRs Medical20070—
+2K041920Infinity Plus Electrotherapy SystemEmpi20050—
+2K042057Infinity Electrotherapy SystemEmpi20040—
+2K034005SDS-4ISkylark Device & Systems Co., Ltd.20040—
+2K023050Reliant BTL 5000 Puls Electrical Stimulation System, Reliant BTL 5000 Sono Ultrasound…Reliant Technologies, Inc.20030—
+3K221958Flex-MIEmsi, Inc.20220—
+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—
+3K150413QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorCymedica Orthopedics, Inc.20157—
+3K124016Empi PhoenixDjo, LLC201325—
+4K212832TimeWaver FrequencyTimewaver Production GmbH20211—
+4K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc.20164—
+4K153704StriveDjo, LLC201624—
+5K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+5K210674Shoulder PacemakerNcs Lab Srl20211—
+5K210604Intellihab SystemCymedica Orthopedics, Inc.20211—
+5K182203JKH Stimulator PlusJkh USA, LLC20197—
+5K170918Compex Sport EliteDjo, LLC20174—
+5K170903Compex Wireless USADjo, LLC201710—
+6K252767actiTENS miniSublimed20260—
+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—
+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—
+7K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+8K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—