510(k) K241512

Electrode Pad by Shenzhen Deliduo Medical Technology Co.,Ltd — Product Code GXY

K241512 is an FDA 510(k) premarket notification submitted by Shenzhen Deliduo Medical Technology Co.,Ltd for the device "Electrode Pad". The FDA issued a decision of Substantially Equivalent on January 15, 2025. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2025
Date Received
May 29, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type