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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 K171803
Device Name HIVOX OTC Electrical Stimulator
Applicant
Hivox Biotek Inc.
5F., No. 123, Xingde Rd.
Sanchong Dist.
New Taipei City,  TW 24158
Applicant Contact Linda Lin
Correspondent
Hivox Biotek Inc.
5F., No. 123, Xingde Rd.
Sanchong Dist.
New Taipei City,  TW 24158
Correspondent Contact Linda Lin
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received06/19/2017
Decision Date 11/29/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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