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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 K151279
Device Name Counter OTC TENS Device, Model CSD-737Z
Applicant
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD
2ND &3RD FLOOR, BLD. 6,
DAPIAN INDUSTRIAL ZONE, TANGXIA RD., TIANHE DISTRICT
GUANGZHOU,  CN 510665
Applicant Contact Jiang Eagle
Correspondent
Media Trade Corporation
11820 RED HIBISCUS DRIVE
BONITA SPRINGS,  FL  34135
Correspondent Contact Guenter Ginsberg
Regulation Number882.5890
Classification Product Code
NUH  
Date Received05/14/2015
Decision Date 12/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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