510(k) Report

Devices descending from K180637

3 later devices reach leva Pelvic Floor Trainer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192270LEva Pelvic Digital Health SystemRenovia, Inc.20192—
+2K212495Leva Pelvic Health SystemRenovia, Inc.20211—
+3K213913leva Pelvic Health SystemRenovia, Inc.20220—