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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K241512
Device Name Electrode Pad
Applicant
Shenzhen Deliduo Medical Technology Co.,Ltd
4th Floor, Bldg. 11, Phase Ii, Meilonghu Intelligent Manu
Facturing Industry New City, Xinwei Town, Huiyang District,
Huizhou,  CN
Applicant Contact Andy Liu
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Wu Jarvis
Regulation Number882.1320
Classification Product Code
GXY  
Date Received05/29/2024
Decision Date 01/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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