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DOMINO SRL · Model DIACARE 5500 PRO · UDI-DI 08032625821137

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The Diacare is a diathermy device that generates a high frequency sinusoidal current with a monopolar and bipolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a hand-held electrode is manipulated by a therapist. When the electrode is in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in capacitive and resistive monopolar modes. T

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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Data 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.