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FDA 510(k)

Well-Life Incontinence Stimulation System (WL-2405i(P))

Número K: K251760 · 2026-02-12

RequerenteWell-Life Healthcare , Ltd.
Data da decisão2026-02-12
Código do produtoKPI
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Well-Life Incontinence Stimulation System (WL-2405i(P)) is the device name listed in this FDA 510(k) record. The listed applicant is Well-Life Healthcare , Ltd.. It received FDA 510(k) clearance on 2026-02-12 under 510(k) number K251760. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Well-Life Incontinence Stimulation System (WL-2405i(P))?

Well-Life Incontinence Stimulation System (WL-2405i(P)) is a medical device that received FDA 510(k) clearance on 2026-02-12. The listed applicant is Well-Life Healthcare , Ltd.. The 510(k) number is K251760.

When did Well-Life Incontinence Stimulation System (WL-2405i(P)) receive FDA 510(k) clearance?

Well-Life Incontinence Stimulation System (WL-2405i(P)) received FDA 510(k) clearance on 2026-02-12, under 510(k) number K251760.

Who is the listed applicant for Well-Life Incontinence Stimulation System (WL-2405i(P))?

The FDA 510(k) record lists Well-Life Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Well-Life Incontinence Stimulation System (WL-2405i(P))?

The FDA product code for Well-Life Incontinence Stimulation System (WL-2405i(P)) is KPI.

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Dispositivos Relacionados (Código: KPI)

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