510(k) Report

Devices descending from K021115

4 later devices reach Gyneflex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122800Inner PeaceKamabry, Inc., Dba Inner Peace For Women20130—
+1K121902NatratoneOrelle Corporation, Ltd.20132—
+2K171896Feminine Personal Trainer (FPT)Ralston Group20171—
+3K193364Intimate Rose Kegel Exercise SystemPlus EV Holdings Dba Intimate Rose20200—