Cleared Traditional

Electrode Pad

K241512 · Shenzhen Deliduo Medical Technology Co.,Ltd · Neurology

Jan 2025

Decision

231d

Days

Class 2

Risk

About This 510(k) Submission

K241512 is an FDA 510(k) clearance for the Electrode Pad, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Shenzhen Deliduo Medical Technology Co.,Ltd (Huizhou, CN). The FDA issued a Cleared decision on January 15, 2025, 231 days after receiving the submission on May 29, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number	K241512 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 29, 2024
Decision Date	January 15, 2025
Days to Decision	231 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF