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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 K140650
Device Name HIVOX ELECTRIC STIMULATOR OTC TENS
Applicant
Hivox Biotek, Inc.
8 F.,# 98, Shinde Rd.,
Sanchong City
Taipei Hsien,  TW 24158
Applicant Contact Ke-Min Jen
Correspondent
Hivox Biotek, Inc.
8 F.,# 98, Shinde Rd.,
Sanchong City
Taipei Hsien,  TW 24158
Correspondent Contact Ke-Min Jen
Regulation Number882.5890
Classification Product Code
NUH  
Date Received03/13/2014
Decision Date 06/27/2014
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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