Clearance Summary
Well-Life Incontinence Stimulation System (WL-2405i(P)) received FDA 510(k) clearance under submission number K251760, sponsored by Well-Life Healthcare , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2026-02-12.
- Submission: K251760
- Applicant / Sponsor: Well-Life Healthcare , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5320
- Decision date: 2026-02-12
Classification & Regulation
This clearance is catalogued under FDA product code KPI and 21 CFR 876.5320, within the Gastroenterology, Urology review panel as a Class II device.