Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2

Stimulator, Nerve, Transcutaneous, Over-the-counter

Hivox Biotek Inc.

The following data is part of a premarket notification filed by Hivox Biotek Inc. with the FDA for Heating Tens/ems Device, Ft-240-1, Heating Tens/ems Device, Ft-240-2.

Pre-market Notification Details

Device IDK221384
510k NumberK221384
Device Name:Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Hivox Biotek Inc. 5F., No. 123, Xingde Rd., Sanchong Dist. New Taipei City,  TW 24158
ContactAaron Huang
CorrespondentAaron Huang
Hivox Biotek Inc. 5F., No. 123, Xingde Rd., Sanchong Dist. New Taipei City,  TW 24158
Product CodeNUH  
Subsequent Product CodeIRT
Subsequent Product CodeNGX
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-13
Decision Date2022-06-11

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