Home › SOFWAVE MEDICAL LTD › SofWave Pure Impact Electode Pads
SofWave Pure Impact Electode Pads
SOFWAVE MEDICAL LTD · Model FG00015 · UDI-DI 17290018152154
4
510(k) clearances
99
Adverse events
3
Recalls
207
Facilities
Description
Electrode Pads for Powered Muscle Stimulator (EMS)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-01-13 | BEMER INT. AG | There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of a pacemaker. |
| 2013-05-23 | Pinook-Usa | Failure to submit a premarket submission and gain approval of a medical device. |
| 2013-05-23 | Pinook-Usa | Failure to submit a premarket submission and gain approval of a medical device. |
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.