510(k) Report

Devices descending from K021100

48 later devices reach 300 PV Complete Electrotherapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141812Mygait Stimulation SystemOtto Bock Healthcare Products GmbH20151—
+1K140467Flex-MT +Emsi20140—
+1K131923Neurodyn Portable Tens Nfes, Neurodyn Portable TensTechlink International20140—
+1K131917Neurodyn Compact, Neurodyn IIIbramed Equipamentos Medicos20141—
+1K131629Neurodyn Multiwave, Aussie SportIbramed Equipamentos Medicos20131—
+1K110350Kneehab XPBio-Medical Research, Ltd.20119—
+1K093324Empi ContinuumEmpi201026—
+1K041920Infinity Plus Electrotherapy SystemEmpi20050—
+1K042057Infinity Electrotherapy SystemEmpi20040—
+1K023050Reliant BTL 5000 Puls Electrical Stimulation System, Reliant BTL 5000 Sono Ultrasound…Reliant Technologies, Inc.20030—
+2K202110MStim Drop Model: LGT-233Guangzhou Longest Science & Technology Co., Ltd.20210—
+2K210572Neurodyn V2.0, Neurodyn Aussie V2.0Ibramed Equipamentos Medicos20210—
+2K181645StimaWELL 120MTRSPierenkemper GmbH20200—
+2K191587L360 Thigh SystemBioness, Inc.20190—
+2K150413QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorCymedica Orthopedics, Inc.20157—
+2K124016Empi PhoenixDjo, LLC201325—
+3K212832TimeWaver FrequencyTimewaver Production GmbH20211—
+3K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc.20164—
+3K153704StriveDjo, LLC201624—
+4K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+4K210674Shoulder PacemakerNcs Lab Srl20211—
+4K210604Intellihab SystemCymedica Orthopedics, Inc.20211—
+4K182203JKH Stimulator PlusJkh USA, LLC20197—
+4K170918Compex Sport EliteDjo, LLC20174—
+4K170903Compex Wireless USADjo, LLC201710—
+5K252767actiTENS miniSublimed20260—
+5K220994Shoulder PacemakerTMNcs Lab Srl20220—
+5K220738Motive Knee WrapCymedica Orthopedics, Inc.20220—
+5K202159actiTENSSublimed20201—
+5K201653Compex Sport Elite 3.0Djo, LLC20202—
+5K201845Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)Guangzhou Longest Science & Technology Co., Ltd.20200—
+5K182020Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd.20200—
+5K190966Katalyst Training SystemKatalyst, Inc.20203—
+5K191151JKH Stimulator PlusJkh USA, LLC20194—
+5K181419Flix-EmsCasgarum Investment, S.L.20190—
+5K181955WiEMSproMedical Cables S.L.20193—
+6K253636Zionic Pro Max (EMS)Termosalud S.L.20260—
+6K252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.20250—
+6K233770Pepper EMS Training SystemPepper Interactive, Inc.20250—
+6K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+6K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc.20231—
+6K230261Gnesis EMS PlusCreative Fitness Developments S.L.20230—
+6K222386VisionbodyVb Technologies AG20230—
+6K221498Miha Bodytec IIMiha Bodytec GmbH20220—
+6K211298WiEMSproMedical Cables S.L.20220—
+6K212413I-MotionI-Motion Group Global Iberica S.L.20221—
+6K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+7K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—