510(k) Report

Devices descending from K160758

3 later devices reach PeriCoach OTC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221476PerifitX6 Innovations20232—
+2K231780Perifit Care+X6 Innovations20231—
+3K252748Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd.20260—