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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 K223308
Device Name HEATING TENS/EMS, FT-810R
Applicant
Hivox Biotek Inc.
5F., No. 123, Xingde Rd.
Sanchong Dist.
New Taipei City,  TW 24158
Applicant Contact Shaun Hsu
Correspondent
Hivox Biotek Inc.
5F., No. 123, Xingde Rd.
Sanchong Dist.
New Taipei City,  TW 24158
Correspondent Contact Shaun Hsu
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
IRT  
Date Received10/28/2022
Decision Date 05/13/2023
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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