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FDA 510(k)

HEATING TENS/EMS, FT-810R

K-Number: K223308 · 2023-05-13

ApplicantHivox Biotek, Inc.
Decision Date2023-05-13
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HEATING TENS/EMS, FT-810R is a medical device manufactured by Hivox Biotek, Inc.. It received FDA 510(k) clearance on 2023-05-13 under approval number K223308. 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, FT-810R?

HEATING TENS/EMS, FT-810R is a medical device that received FDA 510(k) clearance on 2023-05-13. It is manufactured by Hivox Biotek, Inc.. The 510(k) number is K223308.

When was HEATING TENS/EMS, FT-810R approved by the FDA?

HEATING TENS/EMS, FT-810R received FDA 510(k) clearance on 2023-05-13, under approval number K223308.

What company makes HEATING TENS/EMS, FT-810R?

HEATING TENS/EMS, FT-810R is manufactured by Hivox Biotek, Inc..

What is the FDA product code for HEATING TENS/EMS, FT-810R?

The FDA product code for HEATING TENS/EMS, FT-810R is NUH.

Other Devices by Hivox Biotek, Inc.

K171803HIVOX OTC Electrical Stimulator K192264HIVOX Spopad EMS SP-911, SP-921 K190347HIVOX OTC Electrical Stimulator K211403HIVOX OTC Electrical Stimulator, FT610-B 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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Related Devices (Code: 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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