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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning
510(k) Number K212948
Device Name Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)
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 511400
Correspondent Contact Cassie Lee
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Codes
GZJ   IPF   NUH   NYN  
Date Received09/16/2021
Decision Date 11/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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