FDA 510(k)

Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)

Número K: K221199 · 2023-12-19

RequerenteGreen Island International Tcm Group Limited

Data da decisão2023-12-19

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) is the device name listed in this FDA 510(k) record. The listed applicant is Green Island International Tcm Group Limited. It received FDA 510(k) clearance on 2023-12-19 under 510(k) number K221199. 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 Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)?

Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) is a medical device that received FDA 510(k) clearance on 2023-12-19. The listed applicant is Green Island International Tcm Group Limited. The 510(k) number is K221199.

When did Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) receive FDA 510(k) clearance?

Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) received FDA 510(k) clearance on 2023-12-19, under 510(k) number K221199.

Who is the listed applicant for Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)?

The FDA 510(k) record lists Green Island International Tcm Group Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)?

The FDA product code for Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) is GXY.

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Fonte oficial

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