510(k) K252439

Tutamen Self Adhesive Electrodes by Dongguan Tutamen Metalwork Co., Ltd. — Product Code GXY

K252439 is an FDA 510(k) premarket notification submitted by Dongguan Tutamen Metalwork Co., Ltd. for the device "Tutamen Self Adhesive Electrodes". The FDA issued a decision of Substantially Equivalent on May 1, 2026. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Dongguan Tutamen Metalwork Co., Ltd. has at least 1 other 510(k) clearance on record.