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Flyte In-Home Pelvic Floor Treatment

PELVITAL USA, INC. · Model MTI-1 · UDI-DI 00860331002018

HIR
1
510(k) clearances
2
Adverse events
1
Recalls
26
Facilities

Recalls

DateFirmReason
2019-07-12Ralston GroupThe device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Additionally, the firm did not submit a 510k for the de

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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.