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Stimulator, Muscle, Powered
FDA product code IPF · Class 2 · Physical Medicine
956
Registered devices
678
Adverse events
7
Recalls
548
510(k) clearances
Devices with this code
e-vive II NMES System; 2XL/3XL, Right (ITALIAN) — Motive Health, Inc.QB1 NMES System — Motive Health, Inc.NESS L300 Foot Drop System — BIONESS INC.geko — FIRSTKIND LTDL300 Go System — BIONESS INC.CIONIC — Cionic, Inc.MyndMove — MyndTec IncManaFlexx 2 — Manamed, Inc.Richmar EMG Pro — Drive Devilbiss HealthcareRENPHO — Joicom CorporationMyOnyx Mobile App — Thought Technology Ltd.MyndMove — MyndTec IncL360 Thigh System — Bioness Medical, Inc.EMG/Stimulation sensor — Edan Instruments, Inc.L300 Go System — Bioness Medical, Inc.Stimulation Electrode Cable (Lilac) — Otto Bock Healthcare Products GmbHTranscutaneous Electrical Nerve Stimulator — Shenzhen Kentro Medical Electronics Co.,LtdNESS L300-Plus System — BIONESS INC.GEM-STIM — GEMORE TECHNOLOGY CO., LTD.Neurotech Plus — THERAGEN, LLCCOMPEX — DJO, LLCPrelivia Electrode — Rehabtronics IncReGrasp — Rehabtronics IncGEM-STIM — GEMORE TECHNOLOGY CO., LTD.
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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