FDA 510(k)

Everyway Incontinence Stimulation System

N.º K: K213116 · 2021-12-03

SolicitanteEveryway Medical Instruments Co.,Ltd

Fecha de decisión2021-12-03

Código de productoKPI

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Everyway Medical Instruments Co.,Ltd como solicitante

K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 K222488Everyway Analog OTC TENS K202849Everyway Analog OTC TENS, model N103A/N302 K202470Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 K202317Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 K201335Li-Battery powered OTC TENS/EMS Combination Stimulator

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Fuente oficial

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