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proudP
Soundable Health, Inc. · Model SU-UFM-001 · UDI-DI 00860006184902
EXY
Prescription
10
510(k) clearances
2
Adverse events
2
Recalls
43
Facilities
Description
proudP is a mobile application intended for measuring voided volume of urine and urine flow rate using the sound recorded by microphone in mobile devices. This device can be used for assessment of voiding function. This device can be used at home and required to be used in a quiet environment. This device targets patients over 18 years of age.
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.