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Stimulator, Muscle, Powered
FDA product code IPF · Class 2 · Physical Medicine
917
Registered devices
678
Adverse events
7
Recalls
548
510(k) clearances
Devices with this code
MyndMove — MyndTec IncTENSnet 3MT — CLINICAL HEALTH SERVICES, INC.MyndMove — MyndTec Inccase sticker — Otto Bock Healthcare Products GmbHePower® T2 DIGITAL TENS — CLINICAL HEALTH SERVICES, INC.L300 Go System — Bioness Medical, Inc.L100 Go System — Bioness Medical, Inc.InBellaBody System — Inbella Medical IncNeoTone — MAGIC RACE LLCFamidoc — Famidoc Technology Co.,Ltd.WINNER EVO PACKAGE — COMPASS HEALTH BRANDS CORP.QB1 NMES System — Motive Health, Inc.Everyway — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.e-vive NMES System with Post-Op Brace; Small/Medium, Left (2.0 Dock) — Motive Health, Inc.CHATTANOOGA — DJO, LLCCIONIC — Cionic, Inc.QB1 NMES System — Motive Health, Inc.e-vive II NMES System with Post-Op Brace; S/M, Right (ITALIAN) — Motive Health, Inc.Winner EVO Stim — COMPASS HEALTH BRANDS CORP.NeoTone — MAGIC RACE LLCMyndMove — MyndTec IncVEINOPLUS — AD REM TECHNOLOGYROOVJOY — Shenzhen roundwhale technology co. LTD.Stimulation Electrode Cable (green) — Otto Bock Healthcare Products GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-03 | Liberty Medical Solutions, LLC | The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and con |
| 2012-01-06 | Ion Genius, Inc. | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510( |
| 2012-01-06 | Ion Genius, Inc. | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510( |
| 2012-01-06 | Ion Genius, Inc. | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510( |
| 2011-06-22 | eSwallow USA LLC | It was discovered that the firm was distributing medical devices without FDA approval. |
| 2009-01-25 | Zynex Medical, Inc. | Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to th |
| 2008-06-11 | International Rehabilitative Sciences, Inc. | The charge current is leaking through two Diodes, which are supposed to block the reverse current, when the device is warm during the main battery charge operat |
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