510(k) Report

Devices descending from K142506

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191312Perfect PFETenscare, Ltd.20193—
+2K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.20260—
+2K251760Well-Life Incontinence Stimulation System (WL-2405i (P))Well-Life Healthcare, Ltd.20260—
+2K230983Unicare (K-UNICARE-USA)Tenscare, Ltd.20230—