Well-Life Incontinence Stimulation System (WL-2405i(P))— 510(k) K251760
Substantially EquivalentWell-Life Healthcare , Ltd.
FDA 510(k) clearance K251760 for Well-Life Incontinence Stimulation System (WL-2405i(P)), Substantially Equivalent on 2026-02-12. Applicant: Well-Life Healthcare , Ltd.. Device class: 2.
Summary
Well-Life Healthcare's Well-Life Incontinence Stimulation System (WL-2405i(P)) is filed under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 876.5320. Gastroenterology, Urology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Well-Life Healthcare filed from New Taipei City, Taiwan. Review took 248 calendar days (June 9, 2025 to February 12, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Well-Life Healthcare , Ltd.
- Product code
- Product code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Taipei City, TW
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Data sourced from openFDA. This site is unofficial and independent of the FDA.