Home › METTLER ELECTRONICS CORP. › Sys*Stim 206
Sys*Stim 206
METTLER ELECTRONICS CORP. · Model ME 206 · UDI-DI 00816864020005
IPF
Prescription
1
510(k) clearances
678
Adverse events (1 deaths)
7
Recalls
174
Facilities
Description
Powered muscle stimulator, one channel neuromuscular stimulator
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 contraindications. |
| 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(k) or PMA |
| 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(k) or PMA |
| 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(k) or PMA |
| 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 the touch. |
| 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 operation, it then causes |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.