Home › SOFWAVE MEDICAL LTD › Sofwave
Sofwave
SOFWAVE MEDICAL LTD · Model FG00001 · UDI-DI 07290018152003
11
510(k) clearances
216
Adverse events
1
Recalls
17
Facilities
Description
FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION AND A POWERED MUSCLE STIMULATOR (EMS)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-30 | RoyalVibe Health Ltd. | Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance characteristics have not been adequately established. There is a possibility of cust |
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.