K251760 is an FDA 510(k) clearance for the Well-Life Incontinence Stimulation System (WL-2405i(P)). This device is classified as a Stimulator, Electrical, Non-implantable, For Incontinence (Class II - Special Controls, product code KPI).
Submitted by Well-Life Healthcare , Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on February 12, 2026, 248 days after receiving the submission on June 9, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5320.
| 510(k) Number | K251760 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2025 |
| Decision Date | February 12, 2026 |
| Days to Decision | 248 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KPI - Stimulator, Electrical, Non-implantable, For Incontinence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5320 |