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CHATTANOOGA

DJO, LLC · Model 19365 · UDI-DI 00190446650973

GZI
10
510(k) clearances
50
Adverse events (1 deaths)
2
Recalls
40
Facilities

Description

RPW V-ACTOR HF HANDPIECE INCL V25 AND V40 TRANSMITTERS

Recalls

DateFirmReason
2022-07-19Myolyn Inc.Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
2008-08-06Innovative Neurotronics, Inc.Knob responsible for regulating the amount of stimulation administered by the WalkAide System control unit may fall off while device is in use.

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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.