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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 K150277
Device Name Pain Therapy System, Model PTS-II
Applicant
Counter Scientific Development (Gz), Ltd.
2nd &3rd Floor, Bld. 6,
Dapian Industrial Zone, Tangzia Rd., Tianhe District
Guangzhou,  CN 510665
Applicant Contact Eagle Eagle
Correspondent
Media Trade Corporation
11820 Red Hibiscus Dr.
Bonita Springs,  FL  34135
Correspondent Contact GUENTER GINSBERG
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
GZJ   NGX   NYN  
Date Received02/05/2015
Decision Date 02/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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