Stimulator, Muscle, Powered
FDA product code IPF · Class II (moderate risk) · 21 CFR 890.5850 · Physical Medicine
548510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Rich-Mar Corp. 17
- Chattanooga Group, Inc. 14
- Bloomex International, Inc. 14
- Mettler Electronics Corp. 13
- Maximum Performance Technologies, Mpts, Inc. 11
- Firstkind Limited 10
- Empi 8
- Rs Medical 8
- Electro Med Supply, Inc. 7
- Biomedical Life Systems, Inc. 7
- Bio-Medical Research, Ltd. 7
- Excel Tech. , Ltd. 6
- Nor-Am Patient Care Products, Inc. 5
- Medtronic Vascular 5
- Metron Medical Australia, Pty, Ltd. 5
- Djo, LLC 4
- Medical Devices, Inc. 4
- Dan Med, Inc. 4
- Shenzhen Dongdixin Technology Co., Ltd. 4
- Progressive Electrical Therapeutics 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M)IPF · Traditional | Weero Co., Ltd. | 06/08/2026SE |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP)IPF · Traditional | Mohammadali Nezakati | 06/02/2026SE |
| K260142 | StimelMD (SSMD) systemIPF · Special | Motion Informatics ltd. | 05/27/2026SE |
| K251083 | Compact IIIPF · Traditional | Enraf-Nonius, B.V. | 09/12/2025SE |
| K241433 | EVE Synergy (EVE-20M)IPF · Traditional | Weero Co., Ltd. | 06/04/2025SE |
| K241488 | TrainFES AdvanceIPF · Traditional | Trainfes | 02/05/2025SE |
| K240348 | Quantum Mitohormesis (QMT) (M2101)IPF · Abbreviated | Quantumtx Pte. , Ltd. | 12/19/2024SE |
| K240992 | eMVFit (MVF-10M)IPF · Traditional | Weero Co., Ltd. | 10/10/2024SE |
| K240234 | BTL-899MSIPF · Traditional | BTL Industries, Inc. | 08/17/2024SE |
| K233098 | MYOTouch Muscle StimulatorIPF · Traditional | Sunmed, LLC | 08/02/2024SE |
| K232786 | Stimulation System (PA series, PR series, S series and Q series)IPF · Traditional | Edan Instruments, Inc. | 05/16/2024SE |
| K233926 | accufitIPF · Traditional | Mettler Electronics Corporation | 03/21/2024SE |
| K233485 | M-WaveIPF · Abbreviated | Zynex Medical, Inc. | 01/26/2024SE |
| K232937 | BTL-899MIPF · Traditional | BTL Industries, Inc. | 12/26/2023SE |
| K230701 | Stim2GoIPF · Traditional | PAJUNK GmbH Medizintechnologie | 11/24/2023SE |
| K231440 | Combo Electrotherapy DeviceIPF · Traditional | Shenzhen Roundwhale Technology Co. , Ltd. | 11/03/2023SE |
| K223027 | NeuroTrigger Basic (NTB)IPF · Traditional | Neurotrigger | 10/10/2023SE |
| K223802 | accufitIPF · Traditional | Mettler Electronics Corporation | 10/06/2023SE |
| K221274 | StarFormer, TightWaveIPF · Traditional | Fotona D.O.O. | 09/29/2023SE |
| K230167 | Back 4IPF · Traditional | Swims America Corp | 09/14/2023SE |
| K232334 | Deka SimonIPF · Special | El.En S.P.A. | 09/01/2023SE |
| K213655 | HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)IPF · Traditional | Hilltek, LLC | 01/17/2023SE |
| K222201 | Biological Feedback and Stimulation SystemIPF · Traditional | Medlander Medical Technology, Inc. | 10/21/2022SE |
| K221958 | Flex-MIIPF · Traditional | Emsi, Inc. | 10/21/2022SE |
| K220994 | Shoulder PacemakerTMIPF · Traditional | Ncs Lab Srl | 10/14/2022SE |
| K213197 | MyOnyx SystemIPF · Traditional | Thought Technology , Ltd. | 06/17/2022SE |
| K220738 | Motive Knee WrapIPF · Traditional | Cymedica Orthopedics, Inc. | 05/12/2022SE |
| K220327 | geko W-3IPF · Special | Firstkind Limited | 03/04/2022SE |
| K213043 | Levator Elite (Model LE9011)IPF · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 02/25/2022SE |
| K212832 | TimeWaver FrequencyIPF · Traditional | Timewaver Production GmbH | 12/14/2021SE |
| K212762 | geko W-2IPF · Traditional | Firstkind Limited | 11/29/2021SE |
| K192746 | MyoWorx TM20IPF · Traditional | Myoworx, Inc. | 10/19/2021SE |
| K210002 | Stella BioIPF · Traditional | Egzotech Sp. Z O. O. | 10/01/2021SE |
| K210674 | Shoulder PacemakerIPF · Traditional | Ncs Lab Srl | 08/24/2021SE |
| K210938 | PowerDot PD-01MT2 Muscle StimulatorIPF · Special | Smartmissimo Technologies Pte, Ltd. | 07/30/2021SE |
| K211094 | Nerve and Muscle StimulatorIPF · Traditional | Shenzhen Xft Medical Limited | 07/08/2021SE |
| K210604 | Intellihab SystemIPF · Traditional | Cymedica Orthopedics, Inc. | 06/03/2021SE |
| K210979 | PreliviaIPF · Traditional | Rehabtronics, Inc. | 05/13/2021SE |
| K210572 | Neurodyn V2.0, Neurodyn Aussie V2.0IPF · Traditional | Ibramed Equipamentos Medicos | 05/11/2021SE |
| K202031 | Talent-Pro Electromagnetic StimulatorIPF · Traditional | Remed Co., Ltd. | 05/06/2021SE |
| K203710 | Storz Medical MAGNETOLITH Muscle StimulatorIPF · Traditional | Storz Medical AG | 05/03/2021SE |
| K201285 | InMode Evolve System with the Tone ApplicatorIPF · Traditional | InMode , Ltd. | 03/05/2021SE |
| K210269 | PowerDot PD-01MT2 Muscle StimulatorIPF · Special | Smartmissimo Technologies Pte, Ltd. | 02/23/2021SE |
| K203488 | emFieldIPF · Traditional | Zimmer Medizinsysteme GmbH | 02/19/2021SE |
| K202648 | Biofeedback Nerve and Muscle StimulatorIPF · Traditional | Shenzhen Konmed Technology Co., Ltd. | 12/08/2020SE |
| K202079 | PhysiqIPF · Traditional | El.En Electronic Engineering Spa | 11/25/2020SE |
| K202490 | Avid CT2IPF · Traditional | Vision Quest Industries Inc./Dba VQ Orthocare | 11/16/2020SE |
| K200088 | g.Estim FESIPF · Traditional | G.Tec Medical Engineering GmbH | 10/29/2020SE |
| K201290 | Medline DeNovo 4Pro Electrical Stimulation DeviceIPF · Traditional | Medline Industries, Inc. | 09/21/2020SE |
| K201958 | ETD Family of Electrotherapy DevicesIPF · Traditional | Therasigma, LLC | 08/04/2020SE |
| K193275 | Nerve and Muscle StimulatorIPF · Traditional | Shenzhen Xft Medical Limited | 04/11/2020SE |
| K193045 | geko W-2IPF · Special | Firstkind Limited | 01/18/2020SE |
| K183074 | TENS and EMS Stimulator, TENS StimulatorIPF · Traditional | Astek Technology , Ltd. | 01/11/2020SE |
| K192733 | RelieforMe TENS/EMS Device Model UPK-GE01IPF · Traditional | Umeheal , Ltd. | 12/23/2019SE |
| K192249 | InMode System with Tone ApplicatorIPF · Traditional | InMode , Ltd. | 12/17/2019SE |
| K191113 | geko T-2 and geko T-3 Neuromuscular StimulatorsIPF · Traditional | Firstkind Limited | 09/18/2019SE |
| K182163 | Shear Stress Therapeutics SST 3000IPF · Traditional | Shear Stress Therapeutics, LLC | 07/09/2019SE |
| K181759 | PowerDot PD-01MTIPF · Abbreviated | Smartmissimo Technologies Pte, Ltd. | 11/09/2018SE |
| K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS StimulatorIPF · Traditional | Shenzhen Roundwhale Technology Co. , Ltd. | 09/07/2018SE |
| K181059 | geko T-3 Neuromuscular StimulatorIPF · Special | Firstkind Limited | 05/23/2018SE |
| K172381 | Digitimer DS7AP Constant Current StimulatorIPF · Traditional | Digitimer , Ltd. | 03/06/2018SE |
| K180082 | geko T-2 and geko Plus R-2IPF · Traditional | Firstkind, Ltd. | 02/11/2018SE |
| K171978 | Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10IPF · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 10/02/2017SE |
| K171071 | StimSox(TM) SystemIPF · Traditional | Stimmed, LLC | 08/09/2017SE |
| K171387 | EMS100 Tri-Wave Combination StimulatorIPF · Special | Elite Medical Supply of New York, LLC | 05/31/2017SE |
| K163125 | geko T-2 and geko Plus R-2 Neuromuscular StimulatorsIPF · Traditional | Firstkind Limited | 04/10/2017SE |
| K162987 | FA100 SCCD (Sequential Continuous Contraction Device)IPF · Traditional | Flowaid Medical Technologies, Corp | 02/14/2017SE |
| K160614 | Xcite Clinical StationIPF · Traditional | Restorative Therapies, Inc. | 12/16/2016SE |
| K163067 | CyMedica e-vive System; CY-1000IPF · Traditional | Cymedica Orthopedics, Inc. | 12/01/2016SE |
| K160992 | HPM-6000IPF · Traditional | BTL Industries, Inc. | 10/21/2016SE |
| K151922 | StimSox(TM) SystemIPF · Traditional | Stimmed, LLC | 04/15/2016SE |
| K153696 | Chattanooga Revolution WirelessIPF · Traditional | Djo, LLC | 04/14/2016SE |
| K160299 | geko(TM) Plus R-2 Neuromuscular StimulatorIPF · Special | Firstkind Limited | 04/08/2016SE |
| K153224 | VitalStim(R) Plus Electrotherapy SystemIPF · Traditional | Djo, LLC | 02/17/2016SE |
| K152677 | geko T-2 Neuromuscular StimulatorIPF · Special | Firstkind Limited | 10/23/2015SE |
| K150742 | Muscle Stimulation System 110IPF · Special | Niveus Medical, Inc. | 07/23/2015SE |
| K150413 | QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorIPF · Traditional | Cymedica Orthopedics, Inc. | 04/02/2015SE |
| K140467 | Flex-Mt +IPF · Traditional | Emsi | 10/07/2014SE |
| K133638 | GekoIPF · Traditional | Firstkind Limited | 08/21/2014SE |
| K131917 | Neurodyn Compact, Neurodyn IIIPF · Traditional | Ibramed Equipamentos Medicos | 04/29/2014SE |
| K132284 | Vectra Neo Clinical Therapy SystemIPF · Traditional | Djo, LLC | 04/10/2014SE |
| K130691 | Electrotherapy Device (Combo Unit)IPF · Traditional | Guangzhou Finecure Medical Equipment Co.,Ltd | 12/20/2013SE |
| K130052 | Tone-A-MaticIPF · Traditional | Tone-A-Matic International, Inc. | 12/20/2013SE |
| K131629 | Neurodyn Multiwave, Aussie SportIPF · Traditional | Ibramed Equipamentos Medicos | 11/26/2013SE |
| K131222 | Ampcare Esp Therapy SystemIPF · Traditional | Ampcare, LLC | 10/31/2013SE |
| K132137 | MultistimIPF · Special | Metron Medical Australia, Pty, Ltd. | 09/12/2013SE |
| K130424 | STIMEL-03IPF · Traditional | Stimel, Ltd. | 07/11/2013SE |
| K123354 | Revitive IxIPF · Traditional | Actegy , Ltd. | 06/28/2013SE |
| K124016 | Empi PhoenixIPF · Abbreviated | Djo, LLC | 05/06/2013SE |
| K123642 | Muscle Stimulation SystemIPF · Traditional | Niveus Medical, Inc. | 03/29/2013SE |
| K120922 | Guardian Dysphagia Dual Channel Nmes UnitIPF · Abbreviated | Selectivemed Components, Inc. | 02/07/2013SE |
| K113010 | FDES100(TENS and EMS Stimulator, FDES102(ED402) TENS StimulatorIPF · Traditional | Famidoc Technology Co., Ltd. | 12/21/2012SE |
| K113017 | Sys*Stim 240IPF · Abbreviated | Mettler Electronics Corp. | 06/26/2012SE |
| K112148 | Powered Muscle StimulatorIPF · Traditional | Valmed, SA | 04/30/2012SE |
| K112348 | RS-4I Muscle StimulatorIPF · Special | Rs Medical | 01/19/2012SE |
| K111279 | Nexwave Combo Muscle Stimulator SystemIPF · Abbreviated | Zynex Medical, Inc. | 09/20/2011SE |
| K103738 | H-WaveIPF · Special | Electronic Waveform Laboratory, Inc. | 06/01/2011SE |
| K100862 | Bodyflow P2CHIPF · Traditional | Physiomed Elektromedizin AG | 04/21/2011SE |
| K092202 | Eswallow Dysphagia Therapy Kit, Pmi Dysphagia Therapy KitIPF · Traditional | Eswallow USA | 02/10/2011SE |
| K102202 | GS 3000IPF · Traditional | Emsi | 11/23/2010SE |
| K093324 | Empi ContinuumIPF · Traditional | Empi | 03/05/2010SE |
| K093138 | MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003IPF · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 02/12/2010SE |
| K100117 | LT3000 Combo Stimulator, LT3001 TENS Stimulatory, LT3002 EMS StimulatorIPF · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 01/29/2010SE |
| K092791 | Kneehab XP Controller, Model 411IPF · Special | Bio-Medical Research, Ltd. | 12/30/2009SE |
| K093259 | Arp RX100IPF · Traditional | Arp Manufacturing, Inc. | 12/17/2009SE |
| K091248 | Maxems, Models 1000 and 2000IPF · Traditional | Bio Protech, Inc. | 11/30/2009SE |
| K090532 | T.E.A.R. TECH3IPF · Traditional | Vision Quest Industries, Inc. | 11/13/2009SE |
| K083105 | Kneehab XP Conductive Garment, Type 411IPF · Traditional | Bio-Medical Research, Ltd. | 07/24/2009SE |
| K090632 | Compex RehabIPF · Traditional | Chattanooga Group | 06/01/2009SE |
| K080950 | Stiwell MED4IPF · Traditional | Otto Bock, Austria GmbH | 04/02/2009SE |
| K071677 | SRT II Muscle StimulatorIPF · Traditional | Therapeutic Innovations, Inc. | 07/11/2008SE |
| K070888 | Combi 8 MaxIPF · Abbreviated | Cec Electronica S.R.L. | 07/03/2008SE |
| K080787 | Biomove 5000 SystemIPF · Special | Curatronic, Ltd. | 04/17/2008SE |
| K080661 | Models TENS 7000, EMS 7500 and Twin StimIPF · Traditional | Koalaty Products, Inc. | 03/24/2008SE |
| K073361 | Muscle Pain Device (MPD)IPF · Traditional | Stevens Proof of Concept, Inc. | 03/18/2008SE |
| K072252 | Veinoplus Neuromuscular StimulatorIPF · Traditional | Ad Rem Technology Sarl | 01/30/2008SE |
| K063642 | FD EMS, Model # D-FJ30EIPF · Traditional | Fuji Dynamics Limited | 12/13/2007SE |
| K071093 | San Shih Powered Muscle Stimulator, Model 202IPF · Traditional | San Shih Electrical Enterprise Co., Ltd. | 12/06/2007SE |
| K072795 | Models EMS 5.0, EMS 5.1IPF · Traditional | Koalaty Products, Inc. | 11/27/2007SE |
| K071431 | Globus Genesy 1100 StimulatorIPF · Traditional | Domino S.R.L. | 09/21/2007SE |
| K071320 | Everlife Powered Muscle Stimulator, Model E-100204, E-100504, E-100509, E-100804…IPF · Traditional | Everlife Medical Equipment Co., Ltd. | 08/17/2007SE |
| K070425 | Vitalstim ExperiaIPF · Traditional | Chattanooga Group | 06/11/2007SE |
| K062453 | Kingly Star Powered Muscle Stimulator, Model KS-138IPF · Traditional | Kingly Star Intl. Technology Co., Ltd. | 04/17/2007SE |
| K062354 | Vectra Genisys VMS FRIPF · Traditional | Encore Medical L.P. | 01/26/2007SE |
| K053285 | Magbody DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PMIPF · Traditional | Durtech System Corp. | 01/05/2006SE |
| K053266 | Myotrac InfinitiIPF · Traditional | Thought Technology , Ltd. | 12/29/2005SE |
| K050921 | Easystim NMS-28IPF · Abbreviated | Easy Med Instrument Co., Ltd. | 12/12/2005SE |
| K051135 | Axiom NVP8500IPF · Traditional | Axiom Worldwide, Inc. | 08/11/2005SE |
| K050687 | Axiom EPS8000IPF · Traditional | Axiom Worldwide, Inc. | 07/28/2005SE |
| K050847 | If True Sine Interferential Stimulator, Model WL-2206AIPF · Special | Theratech, Inc. | 06/17/2005SE |
| K050595 | FT2000 Sequencer for Muscle StimulatorIPF · Traditional | Midwest Development | 05/23/2005SE |
| K050046 | Rehabilicare If 3 Wave Interferential Stimulator System, Model 7110SIPF · Traditional | Compex Technologies, Inc. | 04/13/2005SE |
| K024258 | Neurotech KneehabIPF · Traditional | Bio-Medical Research, Ltd. | 03/04/2005SE |
| K041390 | Diamond MedistimIPF · Traditional | Diamond Systems USA, Inc. | 02/09/2005SE |
| K042650 | Biomove 3000IPF · Traditional | Curatronic, Ltd. | 01/27/2005SE |
| K041920 | Infinity Plus Electrotherapy SystemIPF · Traditional | Empi | 01/21/2005SE |
| K041063 | Smartwave MS 2000IPF · Traditional | Newwave Medical, LLC | 12/01/2004SE |
| K042881 | PMD-2000 Interferential StimulatorIPF · Traditional | Phoenix Medical Devices, LLC | 11/18/2004SE |
| K034005 | SDS-4IIPF · Traditional | Skylark Device & Systems Co., Ltd. | 11/18/2004SE |
| K040849 | MentamoveIPF · Traditional | Cole & Associates | 10/01/2004SE |
| K032954 | Elpha, Models II 500, II 1000, II 2000, II 3000 and E80IPF · Abbreviated | Danmeter A/S | 08/09/2004SE |
| K033174 | BMLS03-3IPF · Traditional | Biomedical Life Systems, Inc. | 06/30/2004SE |
| K041146 | Control Solutions, Inc., Model CS3102 HVGIPF · Traditional | Control Solutions, Inc. | 06/08/2004SE |
| K031310 | Tai Sheng Various Neox Powered Muscle StimulatorIPF · Traditional | Tai Sheng Electrical Machinery Co., Ltd. | 04/12/2004SE |
| K040306 | High Voltage Pulsed Stimulator, Model BMLS02-7IPF · Traditional | Biomedical Life Systems, Inc. | 03/23/2004SE |
| K032955 | Automove, Model AM800IPF · Abbreviated | Danmeter A/S | 12/15/2003SE |
| K033544 | Electrical Muscle Stimulator, Models N605 and N607IPF · Special | Everyway Medical Instruments Co.,Ltd | 12/10/2003SE |
| K031375 | Besmed Various Models of Powered Muscle Stimulator, BE-560/BE-580IPF · Traditional | Besmed Health Business Corp | 11/20/2003SE |
| K031820 | Electronic Muscle Massage, Models BE-550 and BE-660IPF · Traditional | Multinational | 11/12/2003SE |
| K033140 | Neuromuscular Electrical Stimulator, Model EV-807PIPF · Special | Everyway Medical Instruments Co.,Ltd | 10/29/2003SE |
| K023000 | Home Care Various Models of Powered Muscle Stimulator, HT-329M SeriesIPF · Traditional | Home Care Technology Co., Ltd. | 10/29/2003SE |
| K032941 | Autosound 7.6 Muscle Stimulator, TENS, Therapeutic Ultrasound and Combination DeviceIPF · Special | Rich-Mar Corp. | 10/22/2003SE |
| K032178 | Rhythm Touch Q 2-WAYIPF · Traditional | Shockim Enterprises, Ltd. | 10/15/2003SE |
| K030998 | Medrelief Se Series, Models SE-50, SE-100, SE-200, SE-300IPF · Traditional | Healthonics, Inc. | 10/10/2003SE |
| K032652 | RS-4I Muscle Stimulator FamilyIPF · Traditional | Rs Medical | 09/12/2003SE |
| K031427 | Electro Neuromuscular Stimulator, Model BMLS03-1IPF · Traditional | Biomedical Life Systems, Inc. | 08/19/2003SE |
| K030403 | Cefar Rehab 2 and Rehab 2 ProIPF · Traditional | Cefar Medical AB | 07/17/2003SE |
| K020478 | Electromedicarin 900IPF · Abbreviated | Electromedicarin, S.A. | 07/17/2003SE |
| K031884 | Interferential Stimulator, Model NetwaveIPF · Traditional | Ryan Telemedicine | 06/30/2003SE |
| K024181 | Prizm Medical, Inc. Micro-Z Stimulation SystemIPF · Traditional | Prizm Medical, Inc. | 06/26/2003SE |
| K023036 | Care EtsIPF · Traditional | Care Rehab and Orthopaedic | 06/19/2003SE |
| K031017 | Sys*Stim 208 and 208AIPF · Traditional | Mettler Electronics Corp. | 05/30/2003SE |
| K030507 | T.E.A.R. TECH3 Model #44TT03IPF · Traditional | Vision Quest Industries, Inc. | 05/20/2003SE |
| K022998 | Home Care Vareious Models of Powered Muscle Stimulator, HT-311, HT-311N, HT-312IPF · Traditional | Home Care Technology Co., Ltd. | 05/20/2003SE |
| K023230 | Echopulse Muscle Stimulator System, Model 800IPF · Traditional | Western Clinical Technology Systems, Inc. | 05/05/2003SE |
| K023001 | Home Care Various Models of Powered Muscle Stimulator, HT-326LIPF · Traditional | Home Care Technology Co., Ltd. | 04/08/2003SE |
| K030648 | Vectorsurge 5 Model 470IPF · Special | Metron Medical Australia, Pty, Ltd. | 03/28/2003SE |
| K023997 | Tenscare Ultima Nms/EmsIPF · Traditional | Tenscare, Ltd. | 03/03/2003SE |
| K030254 | Interferential Stimulator, Model RTM1000IPF · Traditional | Ryan Telemedicine | 02/26/2003SE |
| K021588 | Electro Neuromuscular Stimulator, Model BMLS02-5IPF · Traditional | Biomedical Life Systems, Inc. | 02/13/2003SE |
| K023446 | MEDS-3 Neuromuscular StimulatorIPF · Traditional | Medical Equipment Device Specialists | 01/13/2003SE |
| K023439 | MEDS-4 Neuromuscular StimulatorIPF · Traditional | Medical Equipment Device Specialists | 01/13/2003SE |
| K024036 | Product Line-Combo Stimulator/Sequential Stimulator, Model IF-5000IPF · Special | Johari Digital Healthcare , Ltd. | 12/20/2002SE |
| K023347 | Vital StimIPF · Traditional | Chattanooga Group | 12/06/2002SE |
| K020130 | Rolor Powered Muscle Stimulator, Model GP-8016MIPF · Traditional | Rolor Electronics Corp. | 12/02/2002SE |
| K020750 | Digital Electrical Muscle Stimulator, Model EV-807 Digital EMSIPF · Abbreviated | Everyway Medical Instruments Co.,Ltd | 10/31/2002SE |
| K022493 | EMS 400IPF · Traditional | Body Clock Health Care, Ltd. | 10/11/2002SE |
| K022776 | Ness SystemIPF · Special | Ness-Neuromuscular Electrical Stimulation Systems | 09/11/2002SE |
| K022175 | P4 PhysioIPF · Traditional | Valmed Corp. | 09/09/2002SE |
| K021905 | Classic NMSIPF · Traditional | Care Rehab, Inc. | 09/05/2002SE |
| K021472 | HMS-DHR-3 Neuromuscular StimulatorIPF · Traditional | Home Medical Services | 08/06/2002SE |
| K014019 | Neurotech Medistim Plus, Type 291IPF · Traditional | Bio-Medical Research, Ltd. | 07/11/2002SE |
| K013768 | Powered Muscle StimulatorIPF · Traditional | Theratech, Inc. | 07/03/2002SE |
| K021754 | Apex Medical Digital EMS TS1311, TS1312IPF · Special | Apex Medical Corp. | 06/28/2002SE |
| K021100 | 300 PV Complete Electrotherapy SystemIPF · Traditional | Empi | 06/18/2002SE |
| K021763 | RS2MI Muscle Stimulator FamilyIPF · Traditional | Rs Medical | 06/13/2002SE |
| K020637 | Select StimIPF · Traditional | Care Rehab and Orthopaedic | 05/28/2002SE |
| K020684 | Finesun EMS StimulatorIPF · Traditional | Finesun Worldwide Intl. Co., Ltd. | 05/23/2002SE |
| K020314 | Digi-Pro TENS, Model WL-2204 and WL-2205IPF · Traditional | Well-Life Healthcare, Inc. | 04/30/2002SE |
| K011588 | SuretoneIPF · Traditional | Suretone International | 03/28/2002SE |
| K992099 | Bio SPA IntelligentIPF · Traditional | Starbene | 01/18/2002SE |
| K013771 | Modification to: Winner CM-2 Muscle Stimulator, TENS, Therapeutic Ultrasound and…IPF · Special | Rich-Mar Corp. | 01/18/2002SE |
| K013770 | Modification to: Winner ST-2 StimulatorIPF · Special | Rich-Mar Corp. | 01/18/2002SE |
| K013081 | Medstar 150IPF · Traditional | Mednet Services, Inc. | 11/20/2001SE |
| K012885 | Neuromove NM900IPF · Traditional | Dan Med, Inc. | 11/08/2001SE |
| K011913 | Sun-Tens Palm Type R5/COMPACT Wireles M2 EMS SeriesIPF · Traditional | Sun-Rain System Corp. | 10/26/2001SE |
| K000741 | EMS Jumper II Dual Channel Neuromuscular Stimulator System, Model E-188IPF · Traditional | 138 Medical Supplies, Inc. | 10/24/2001SE |
| K010749 | Electro Neuromuscular Stimulator, Model Nms-DigitalIPF · Traditional | Biomedical Life Systems, Inc. | 09/28/2001SE |
| K002339 | Aems V, EMS-1000, Model TS-140500 and Aems Vi, EMS-1000 Plus, Model TS-140600IPF · Traditional | Apex Medical Corp. | 08/24/2001SE |
| K010807 | Muscle Stimulator SA-100IPF · Traditional | Health@Fitness Technologies, Inc. | 08/09/2001SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0506-2024 Class II | Multi-Mode Stimulator, Transcutaneous Electrical Nerve StimulationThe instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did… | Liberty Medical Solutions, LLC | 11/03/2023Open, Classified |
| Z-1141-2012 | Arasys Product Usage: Muscle stimulationWires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations.… | Ion Genius, Inc. | 01/06/2012Terminated |
| Z-1138-2012 | Ion Magnum Product Usage: Muscle stimulationWires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations.… | Ion Genius, Inc. | 01/06/2012Terminated |
| Z-1137-2012 | Perfector Product Usage: Muscle stimulationWires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations.… | Ion Genius, Inc. | 01/06/2012Terminated |
| Z-2880-2011 | eSwallow Multi-Program Dysphagia Therapy Test unit Intended Use: Powered Muscle…It was discovered that the firm was distributing medical devices without FDA approval. | eSwallow USA LLC | 06/22/2011Terminated |
| Z-1874-2014 Class II | IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular…Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and… | Zynex Medical, Inc. | 01/25/2009Terminated |
| Z-0323-2011 | The device is labeled in part: " RS Medical RS-4i Stimulator". The device is sold in a…The charge current is leaking through two Diodes, which are supposed to block the reverse current, when the… | International Rehabilitative Sciences, Inc. | 06/11/2008Terminated |