Tutamen Self Adhesive Electrodes
K-Number: K252439 · 2026-05-01
ApplicantDongguan Tutamen Metalwork Co., Ltd.
Decision Date2026-05-01
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Tutamen Self Adhesive Electrodes is a medical device manufactured by Dongguan Tutamen Metalwork Co., Ltd.. It received FDA 510(k) clearance on 2026-05-01 under approval number K252439. 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 Tutamen Self Adhesive Electrodes?
Tutamen Self Adhesive Electrodes is a medical device that received FDA 510(k) clearance on 2026-05-01. It is manufactured by Dongguan Tutamen Metalwork Co., Ltd.. The 510(k) number is K252439.
When was Tutamen Self Adhesive Electrodes approved by the FDA?
Tutamen Self Adhesive Electrodes received FDA 510(k) clearance on 2026-05-01, under approval number K252439.
What company makes Tutamen Self Adhesive Electrodes?
Tutamen Self Adhesive Electrodes is manufactured by Dongguan Tutamen Metalwork Co., Ltd..
What is the FDA product code for Tutamen Self Adhesive Electrodes?
The FDA product code for Tutamen Self Adhesive Electrodes is GXY.
Related Devices (Code: GXY)
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.