510(k) K251760
K251760 is an FDA 510(k) premarket notification submitted by Well-Life Healthcare , Ltd. for the device "Well-Life Incontinence Stimulation System (WL-2405i(P))". The FDA issued a decision of Substantially Equivalent on February 12, 2026. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Well-Life Healthcare , Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2026
- Date Received
- June 9, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Non-Implantable, For Incontinence
- Device Class
- Class II
- Regulation Number
- 876.5320
- Review Panel
- GU
- Submission Type