About This 510(k) Submission
K251760 is an FDA 510(k) clearance for the Well-Life Incontinence Stimulation System (WL-2405i(P)), 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 review panel. Regulated under 21 CFR 876.5320.