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FDA 510(k)

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

K-Number: K221384 · 2022-06-11

ApplicantHivox Biotek, Inc.
Decision Date2022-06-11
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 is a medical device manufactured by Hivox Biotek, Inc.. It received FDA 510(k) clearance on 2022-06-11 under approval number K221384. 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/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2?

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 is a medical device that received FDA 510(k) clearance on 2022-06-11. It is manufactured by Hivox Biotek, Inc.. The 510(k) number is K221384.

When was Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 approved by the FDA?

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 received FDA 510(k) clearance on 2022-06-11, under approval number K221384.

What company makes Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2?

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 is manufactured by Hivox Biotek, Inc..

What is the FDA product code for Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2?

The FDA product code for Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 is NUH.

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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.

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