FDA 510(k)

Well-Life Garment Electrodes (GM Series)

Número K: K200942 · 2021-06-01

Data da decisão2021-06-01

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Well-Life Garment Electrodes (GM Series) is the device name listed in this FDA 510(k) record. The listed applicant is Well-Life Healthcare Limited. It received FDA 510(k) clearance on 2021-06-01 under 510(k) number K200942. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Well-Life Garment Electrodes (GM Series)?

Well-Life Garment Electrodes (GM Series) is a medical device that received FDA 510(k) clearance on 2021-06-01. The listed applicant is Well-Life Healthcare Limited. The 510(k) number is K200942.

When did Well-Life Garment Electrodes (GM Series) receive FDA 510(k) clearance?

Well-Life Garment Electrodes (GM Series) received FDA 510(k) clearance on 2021-06-01, under 510(k) number K200942.

Who is the listed applicant for Well-Life Garment Electrodes (GM Series)?

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

What is the FDA product code for Well-Life Garment Electrodes (GM Series)?

The FDA product code for Well-Life Garment Electrodes (GM Series) is GXY.

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