FDA 510(k)

Everyway Incontinence Stimulation System

Número K: K213116 · 2021-12-03

RequerenteEveryway Medical Instruments Co.,Ltd

Data da decisão2021-12-03

Código do produtoKPI

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Everyway Incontinence Stimulation System is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K213116. 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 Everyway Incontinence Stimulation System?

Everyway Incontinence Stimulation System is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K213116.

When did Everyway Incontinence Stimulation System receive FDA 510(k) clearance?

Everyway Incontinence Stimulation System received FDA 510(k) clearance on 2021-12-03, under 510(k) number K213116.

Who is the listed applicant for Everyway Incontinence Stimulation System?

The FDA 510(k) record lists Everyway Medical Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Everyway Incontinence Stimulation System?

The FDA product code for Everyway Incontinence Stimulation System is KPI.

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Outros registros que listam Everyway Medical Instruments Co.,Ltd como candidato(a)

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