FDA 510(k)

導電シリコン電極（モデル：足パッド電極、カップリング電極、ポイント電極）

K番号: K221199 · 2023-12-19

申請者Green Island International Tcm Group Limited

決定日2023-12-19

製品コードGXY

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

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.

よくある質問

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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導電シリコン電極（モデル：足パッド電極、カップリング電極、ポイント電極）

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：GXY）

公式ソース