Decision Date2023-01-19
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Self-adhesive Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. It received FDA 510(k) clearance on 2023-01-19 under 510(k) number K222252. 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 Self-adhesive Electrode?
Self-adhesive Electrode is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K222252.
When did Self-adhesive Electrode receive FDA 510(k) clearance?
Self-adhesive Electrode received FDA 510(k) clearance on 2023-01-19, under 510(k) number K222252.
Who is the listed applicant for Self-adhesive Electrode?
The FDA 510(k) record lists Shenzhen Roundwhale Technology Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Self-adhesive Electrode?
The FDA product code for Self-adhesive Electrode 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.