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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 K211403
Device Name HIVOX OTC Electrical Stimulator, FT610-B
Applicant
Hivox Biotek, Inc.
Sf., # 123, Xingde Rd., Sanchong District
New Taipei City,  TW 241
Applicant Contact Ruby Lu
Correspondent
Hivox Biotek, Inc.
Sf., # 123, Xingde Rd., Sanchong District
New Taipei City,  TW 241
Correspondent Contact Ruby Lu
Regulation Number882.5890
Classification Product Code
NUH  
Date Received05/06/2021
Decision Date 10/15/2021
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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