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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 K221384
Device Name Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
Applicant
Hivox Biotek, Inc.
5f., # 123, Xingde Rd., Sanchong Dist.
New Taipei City,  TW 24158
Applicant Contact Aaron Huang
Correspondent
Hivox Biotek, Inc.
5f., # 123, Xingde Rd., Sanchong Dist.
New Taipei City,  TW 24158
Correspondent Contact Aaron Huang
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
IRT   NGX  
Date Received05/13/2022
Decision Date 06/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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