Heating Tens, FT-615
K-Number: K232675 · 2023-10-05
ApplicantHivox Biotek, Inc.
Decision Date2023-10-05
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Heating Tens, FT-615 is a medical device manufactured by Hivox Biotek, Inc.. It received FDA 510(k) clearance on 2023-10-05 under approval number K232675. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Heating Tens, FT-615?
Heating Tens, FT-615 is a medical device that received FDA 510(k) clearance on 2023-10-05. It is manufactured by Hivox Biotek, Inc.. The 510(k) number is K232675.
When was Heating Tens, FT-615 approved by the FDA?
Heating Tens, FT-615 received FDA 510(k) clearance on 2023-10-05, under approval number K232675.
What company makes Heating Tens, FT-615?
Heating Tens, FT-615 is manufactured by Hivox Biotek, Inc..
What is the FDA product code for Heating Tens, FT-615?
The FDA product code for Heating Tens, FT-615 is NUH.
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K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
K221384Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.