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FDA 510(k)

Conductive Gel

K-Number: K221724 · 2022-09-23

ApplicantTone-A-Matic International, Inc.
Decision Date2022-09-23
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Conductive Gel is a medical device manufactured by Tone-A-Matic International, Inc.. It received FDA 510(k) clearance on 2022-09-23 under approval number K221724. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Conductive Gel?

Conductive Gel is a medical device that received FDA 510(k) clearance on 2022-09-23. It is manufactured by Tone-A-Matic International, Inc.. The 510(k) number is K221724.

When was Conductive Gel approved by the FDA?

Conductive Gel received FDA 510(k) clearance on 2022-09-23, under approval number K221724.

What company makes Conductive Gel?

Conductive Gel is manufactured by Tone-A-Matic International, Inc..

What is the FDA product code for Conductive Gel?

The FDA product code for Conductive Gel is GYB.

Other Devices by Tone-A-Matic International, Inc.

K222863Garment Electrodes

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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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