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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 K161537
Device Name OTC TENS Device, Model PTS-IV
Applicant
Counter Scientific Development (Gz), Ltd.
2nd &3rd Floor, Bld.6
Dapian Industrial Zone, Tangxia Rd., Tianhe District
Guangzhou,  CN 510665
Applicant Contact WENDY POON
Correspondent
Media Trade Corporation
11820 Red Hibiscus Dr.
Bonita Springs,  FL  34135
Correspondent Contact GUENTER GINSBERG
Regulation Number882.5890
Classification Product Code
NUH  
Date Received06/03/2016
Decision Date 10/13/2016
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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