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 a medical device manufactured by Tone-A-Matic International, Inc.. It received FDA 510(k) clearance on 2023-02-01 under approval 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. It is manufactured by Tone-A-Matic International, Inc.. The 510(k) number is K222863.
When was Garment Electrodes approved by the FDA?
Garment Electrodes received FDA 510(k) clearance on 2023-02-01, under approval number K222863.
What company makes Garment Electrodes?
Garment Electrodes is manufactured by Tone-A-Matic International, Inc..
What is the FDA product code for Garment Electrodes?
The FDA product code for Garment Electrodes is 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.