# K191312: Perfect PFE

- Pathway: 510(k) (Traditional)
- Applicant: Tenscare, Ltd.
- Decided: Nov 1, 2019 after 170 days
- Product code: KPI (Stimulator, Electrical, Non-Implantable, For Incontinence)
- Device class: 2
- Regulation: 21 CFR 876.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K930530 (1995). 39 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142506: TensCare KegelFit, Tenscare, Ltd. (2015) Summary page 4.
- K141643: Yarlap, International Trade Group, Inc. (2015) Summary page 5.

## Most influential descendants
- K260178: Pelvic Muscle Trainer (KM510, KM516B) (2026), 0 descendants of its own
- K251760: Well-Life Incontinence Stimulation System (WL-2405i (P)) (2026), 0 descendants of its own
- K230983: Unicare (K-UNICARE-USA) (2023), 0 descendants of its own

## Indications for use
Perfect PFE is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

Source page: https://510kreport.com/device/K191312
Methodology: https://510kreport.com/methodology