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Avazzia
AVAZZIA INC · Model A4-EB-K · UDI-DI 00851530007638
10
510(k) clearances
54
Adverse events
2
Recalls
62
Facilities
Description
Ezzi Lift TENS device for aesthetic use with Y electrode, lead wire, owner's manual, and batteries.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-01-06 | Ion Genius, Inc. | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA |
| 2012-01-06 | Ion Genius, Inc. | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA |
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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.