# K251760: Well-Life Incontinence Stimulation System (WL-2405i (P))

- Pathway: 510(k) (Traditional)
- Applicant: Well-Life Healthcare, Ltd.
- Decided: Feb 12, 2026 after 248 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: 11 generations back to K930530 (1995). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191312: Perfect PFE, Tenscare, Ltd. (2019) Summary page 5.

## Indications for use
The Well-Life Incontinence Stimulation System (Model: WL-2405i(P)) is intended to provide neuromuscular electrical stimulation for the rehabilitation and re-education of weak pelvic floor muscles in adult women. It is indicated for the treatment of stress, urge, and mixed urinary incontinence and to help maintain urinary continence.

Source page: https://510kreport.com/device/K251760
Methodology: https://510kreport.com/methodology