510(k) Report

Devices descending from K190058

6 later devices reach PureSleep (OTC use) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220688SilentZPro 2.0Shinrin-Yoku Traders, LLC20221—
+1K222475Snor LockSolbaro Co., Ltd.20220—
+1K213088ZQuiet AdvanceSleeping Well, LLC20221—
+1K210910Snore BanditSnorebandit, LLC20210—
+2K253868QuietLab ProQuietLab, LLC20250—
+2K250028Anti Snore MouthpieceDongguan Yiyao Science & Technology Development Co., Ltd.20250—