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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 K203574
Device Name HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
Applicant
Hivox Biotek, Inc.
Sf., # 123, Xingde Rd., Sanchong District
New Taipei City,  TW 241
Applicant Contact Ruby Lu
Correspondent
Hivox Biotek, Inc.
5f, # 123, Xingde Rd., Sanchong District,
New Taipei City,  TW 241
Correspondent Contact Ruby Lu
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received12/07/2020
Decision Date 03/10/2021
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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