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Replexa+ Treatment Applicator

PROMEDTEK, INC. · Model C1416 · UDI-DI 00850886008016

IMJ Prescription
1
510(k) clearances
25
Adverse events
1
Recalls
16
Facilities

Description

Replexa+ Model C1416 Shortwave Diathermy Treatment Applicator

Recalls

DateFirmReason
2015-08-21DJO, LLCOverheating and burning of the wire insulation inside the applicator.

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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.