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510(k) K251760

Well-Life Incontinence Stimulation System (WL-2405i(P)) by Well-Life Healthcare , Ltd. — Product Code KPI

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

Other clearances by Well-Life Healthcare , Ltd.

  • K040512 — LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2 (May 27, 2004)
  • K033857 — T-TECH DIGITAL, MODEL WL-22XXA SERIES (December 19, 2003)
  • K030537 — DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B (March 20, 2003)
  • K020020 — THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE C (December 30, 2002)
  • K021359 — DIGI-PRO TENS MODEL WL-2203 AND WL-2205 (April 30, 2002)
  • K020314 — DIGI-PRO TENS, MODEL WL-2204 AND WL-2205 (April 30, 2002)

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  • K251026 — Regenesis EMS Chair (August 29, 2025)
  • K243079 — NeuroTrac® MyoPlus Pro (MYO120U) (June 26, 2025)
  • K241862 — Levina Pelvic Floor Muscle Stimulator (RS-48) (March 27, 2025)
  • K241516 — BTL-398 (February 10, 2025)
  • K241899 — Pelvic Floor Stimulator (Intrelief PFE) (November 27, 2024)
  • K234061 — StarFormer (July 1, 2024)
  • K233576 — Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505 (February 23, 2024)
  • K231166 — Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscl (January 18, 2024)
  • K230983 — Unicare (K-UNICARE-USA) (October 20, 2023)
  • K230780 — MFG-05 (October 5, 2023)