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FIZE kUO Console
FIZE RESEARCH LTD · Model 5G2 · UDI-DI 07290019239031
EXY
Prescription
10
510(k) clearances
2
Adverse events
2
Recalls
43
Facilities
Description
FIZE kUO Console 5G catalog number: FI-FG00-KU00-0006 FIZE kUO console 5G with power box US catalog number: FKUO5.0G_PB_US FIZE kUO console 5G with power supply US catalog number: FKUO5.0G_PS_US
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-29 | Emano Metrics, Inc. | Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validat |
| 2022-04-21 | Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) | Due to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may perform automatic processing of the urination sound signal, resulting in lower uri |
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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.