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FDA 510(k)

Adhesive Electrode

K-Number: K210448 · 2021-08-31

ApplicantShaoxing Yingtuo Healthcare Co., Ltd.
Decision Date2021-08-31
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Adhesive Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Shaoxing Yingtuo Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2021-08-31 under 510(k) number K210448. 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 Adhesive Electrode?

Adhesive Electrode is a medical device that received FDA 510(k) clearance on 2021-08-31. The listed applicant is Shaoxing Yingtuo Healthcare Co., Ltd.. The 510(k) number is K210448.

When did Adhesive Electrode receive FDA 510(k) clearance?

Adhesive Electrode received FDA 510(k) clearance on 2021-08-31, under 510(k) number K210448.

Who is the listed applicant for Adhesive Electrode?

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

What is the FDA product code for Adhesive Electrode?

The FDA product code for Adhesive Electrode is GXY.

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Related Devices (Code: GXY)

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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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