FDA 510(k)

TENS Electrodes

Número K: K160081 · 2016-10-19

Data da decisão2016-10-19

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

TENS Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Cathay Manufacturing Corp.. It received FDA 510(k) clearance on 2016-10-19 under 510(k) number K160081. 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 TENS Electrodes?

TENS Electrodes is a medical device that received FDA 510(k) clearance on 2016-10-19. The listed applicant is Cathay Manufacturing Corp.. The 510(k) number is K160081.

When did TENS Electrodes receive FDA 510(k) clearance?

TENS Electrodes received FDA 510(k) clearance on 2016-10-19, under 510(k) number K160081.

Who is the listed applicant for TENS Electrodes?

The FDA 510(k) record lists Cathay Manufacturing Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS Electrodes?

The FDA product code for TENS Electrodes is GXY.

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