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FORMATK SYSTEMS LTD · Model FS10011 · UDI-DI 07290016681277
PBX
Prescription
1
510(k) clearances
63
Adverse events
1
Recalls
75
Facilities
Description
Radiofrequency Applicator to be used with Formatk Systems Ltd supporting systems for minor muscle aches and pain treatments
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-07-13 | Bios S.r.l. | In some systems, the unit continues to emit RF energy after the PAUSE button is pressed. |
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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.