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FDA 510(k)

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

K-Number: K221199 · 2023-12-19

ApplicantGreen Island International Tcm Group Limited
Decision Date2023-12-19
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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