510(k) K251760

Device
Well-Life Incontinence Stimulation System (WL-2405i(P))
Applicant
Well-Life Healthcare , Ltd.
510(k) number
K251760
Product code
KPI
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-12
Date received
2025-06-09
Regulation
876.5320
Classification name
Stimulator, Electrical, Non-Implantable, For Incontinence
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jenny Hsieh
Address
6f. #168, Lide St., Jhonghe District New Taipei City TW 23512 23512

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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