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FDA 510(k)

Garment Electrodes

K-Number: K222863 · 2023-02-01

ApplicantTone-A-Matic International, Inc.
Decision Date2023-02-01
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Garment Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Tone-A-Matic International, Inc.. It received FDA 510(k) clearance on 2023-02-01 under 510(k) number K222863. 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 Garment Electrodes?

Garment Electrodes is a medical device that received FDA 510(k) clearance on 2023-02-01. The listed applicant is Tone-A-Matic International, Inc.. The 510(k) number is K222863.

When did Garment Electrodes receive FDA 510(k) clearance?

Garment Electrodes received FDA 510(k) clearance on 2023-02-01, under 510(k) number K222863.

Who is the listed applicant for Garment Electrodes?

The FDA 510(k) record lists Tone-A-Matic International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Garment Electrodes?

The FDA product code for Garment Electrodes is GXY.

Other records listing Tone-A-Matic International, Inc. as applicant

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.

K221724Conductive Gel

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

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

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