510(k) Report

Devices descending from K191312

3 later devices reach Perfect PFE through their predicates, nearest generation first.

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