Wrap Accessory Electrodes
K-Number: K210383 · 2021-11-12
ApplicantHi-Dow International, Inc.
Decision Date2021-11-12
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Wrap Accessory Electrodes is a medical device manufactured by Hi-Dow International, Inc.. It received FDA 510(k) clearance on 2021-11-12 under approval number K210383. 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 Wrap Accessory Electrodes?
Wrap Accessory Electrodes is a medical device that received FDA 510(k) clearance on 2021-11-12. It is manufactured by Hi-Dow International, Inc.. The 510(k) number is K210383.
When was Wrap Accessory Electrodes approved by the FDA?
Wrap Accessory Electrodes received FDA 510(k) clearance on 2021-11-12, under approval number K210383.
What company makes Wrap Accessory Electrodes?
Wrap Accessory Electrodes is manufactured by Hi-Dow International, Inc..
What is the FDA product code for Wrap Accessory Electrodes?
The FDA product code for Wrap Accessory 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.