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FDA 510(k)

Electrode Market Disposable Surface Electrodes

K-Number: K211839 · 2021-07-28

Decision Date2021-07-28
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Electrode Market Disposable Surface Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Electrode Market Co., Ltd.. It received FDA 510(k) clearance on 2021-07-28 under 510(k) number K211839. 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 Electrode Market Disposable Surface Electrodes?

Electrode Market Disposable Surface Electrodes is a medical device that received FDA 510(k) clearance on 2021-07-28. The listed applicant is Electrode Market Co., Ltd.. The 510(k) number is K211839.

When did Electrode Market Disposable Surface Electrodes receive FDA 510(k) clearance?

Electrode Market Disposable Surface Electrodes received FDA 510(k) clearance on 2021-07-28, under 510(k) number K211839.

Who is the listed applicant for Electrode Market Disposable Surface Electrodes?

The FDA 510(k) record lists Electrode Market Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrode Market Disposable Surface Electrodes?

The FDA product code for Electrode Market Disposable Surface Electrodes is GXY.

Related Clinical Trials

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.

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.

Official Source

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