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BEAGANK 4T PLUS

BELEGA CO.,LTD. · Model 4TP-OTC · UDI-DI 04580678250045

NFO
1
510(k) clearances
37
Adverse events
2
Recalls
60
Facilities

Recalls

DateFirmReason
2012-01-06Ion 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
2012-01-06Ion 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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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.