FDA-Device2022-07-06Class II
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
Hazard
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.
Sold states
Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.
Affected count
41 devices (out of 1,260 users)
Manufactured in
Seocho-Daero, Seocho, # 413 398 Platinum Tower, Seoul, Korea (the Republic of)
Products
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1292-2022Don't want to check this manually?
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