Device product

ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier

Z-1292-2022

April 21, 2022

Class II

Product summary

Firm: Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
Event: Event 90165
Status: Terminated
Classification: Class II
Quantity: 41 devices (out of 1,260 users)
Official record key: device-enforcement:Z-1292-2022

Official wording

Reason: 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 urination volume and velocity values than expected.

Code information: prouP Version - 1.2.0 UDI Code: (01)00860006184902(10)v1.x.x

Distribution pattern: Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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 urination volume and velocity values than expected.