510(k) Report

Devices descending from K013653

5 later devices reach Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133990Ieva Rehabilitative Positional DeviceRemendium Labs, LLC20144—
+2K180637leva Pelvic Floor TrainerRenovia, Inc.20183—
+3K192270LEva Pelvic Digital Health SystemRenovia, Inc.20192—
+4K212495Leva Pelvic Health SystemRenovia, Inc.20211—
+5K213913leva Pelvic Health SystemRenovia, Inc.20220—