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SofWave Pure Impact Wireless Stimulation Module
SOFWAVE MEDICAL LTD · Model FG00014-R · UDI-DI 07290018152096
NGX
Prescription
4
510(k) clearances
99
Adverse events
3
Recalls
207
Facilities
Description
This is a refurbish version of the SofWave Pure Impact Wireless Stimulation Module as part of the 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. |
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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.