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INDIBA DEEP CARE - EVONY
INDIBA SA. · Model IDC0409 · UDI-DI 08434251003084
PBX
Prescription
1
510(k) clearances
63
Adverse events
1
Recalls
73
Facilities
Description
Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories. The Indiba Evony device is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions.
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.