K251760
- 510(k) number
- K251760
- Device name
- Well-Life Incontinence Stimulation System (WL-2405i(P))
- Applicant
- Well-Life Healthcare , Ltd. TW
- Product code
- KPI — Stimulator, Electrical, Non-Implantable, For Inconti
- Decision date
- 2026-02-12
- Date received
- 2025-06-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251760.pdf
Official FDA record: K251760
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.