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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 K190118
Device Name Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
Applicant
Guangzhou Xinbo Electronic Co., Ltd.
23 Bldg., Phase-Ii Huachuang Industry Park
Panyu,  CN 511400
Applicant Contact Sammy Li
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd.
Huangpu District
Guangzhou,  CN 511400
Correspondent Contact Cassie Lee
Regulation Number882.1320
Classification Product Code
GXY  
Date Received01/24/2019
Decision Date 05/13/2020
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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