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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 K190347
Device Name HIVOX OTC Electrical Stimulator
Applicant
Hivox Biotek Inc.
5F., No. 123, Xingde Rd.
Sanchong Dist.
New Taipei City,  TW 24158
Applicant Contact Marx Lee
Correspondent
Hivox Biotek Inc.
5F., No. 123, Xingde Rd.
Sanchong Dist.
New Taipei City,  TW 24158
Correspondent Contact Marx Lee
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received02/14/2019
Decision Date 03/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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