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Provent Sleep Therapy
PROVENT SLEEP THERAPY, LLC · Model CAT1114 · UDI-DI 00868020000215
OHP
Prescription
1
510(k) clearances
4
Adverse events
2
Recalls
3
Facilities
Description
Provent 30 Night Starter Kit contains two (2) Light resistance (Phase 1) non-therapeutic acclimation units, two (2) Medium resistance (Phase 2) non-therapeutic acclimation units, and 26 Standard resistance Provent devices
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-04-13 | American Contract Systems | The surgical gowns were manufactured in a facility that is not registered by the FDA. |
| 2012-02-03 | Ventus Medical, Inc. | A discrepancy was found during inspection of a returned unit that the lot number and SKU on cartoon did not match. |
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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.