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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K202671
Device Name DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)
Applicant
Guangzhou Xinbo Electronic Co., Ltd.
#23 Bldg., The Second Phase,
Huachuang Animation Industry Park, Panyu,
Guangzhou,  CN 511450
Applicant Contact Sammy Li
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 Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
IRT   NGX   NYN  
Date Received09/14/2020
Decision Date 11/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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