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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 K221199
Device Name Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)
Applicant
Green Island International Tcm Group Limited
Flat 566 7/F, Kiu Kin Mansion, 566-568 Nathan Rd., Kowloon,
Hongkong
Hongkong,  CN 999077
Applicant Contact Zhang Shuai
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd., Huangpu
District
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number882.1320
Classification Product Code
GXY  
Date Received04/26/2022
Decision Date 12/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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