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Rivus
NEUROSOFT, OOO · Model Rivus · UDI-DI 04650075339992
10
510(k) clearances
2
Adverse events
2
Recalls
43
Facilities
Description
The uroflowmeter is intended to quantify the flow characteristics of the lower urinary tract. The uroflowmetry is used for patients with urinary incontinence, abnormal urinary retention.
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.