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FIZE kUO Disposable kit Pediatrics

FIZE RESEARCH LTD · Model FI-FGUS-KU03-0030 · UDI-DI 07290019239253

EXY Prescription
10
510(k) clearances
2
Adverse events
2
Recalls
43
Facilities

Recalls

DateFirmReason
2026-05-29Emano 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
2022-04-21Dain 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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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.