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FDA 510(k)

HIVOX OTC Electrical Stimulator

K-Number: K190347 · 2019-03-15

ApplicantHivox Biotek, Inc.
Decision Date2019-03-15
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HIVOX OTC Electrical Stimulator is a medical device manufactured by Hivox Biotek, Inc.. It received FDA 510(k) clearance on 2019-03-15 under approval number K190347. 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 HIVOX OTC Electrical Stimulator?

HIVOX OTC Electrical Stimulator is a medical device that received FDA 510(k) clearance on 2019-03-15. It is manufactured by Hivox Biotek, Inc.. The 510(k) number is K190347.

When was HIVOX OTC Electrical Stimulator approved by the FDA?

HIVOX OTC Electrical Stimulator received FDA 510(k) clearance on 2019-03-15, under approval number K190347.

What company makes HIVOX OTC Electrical Stimulator?

HIVOX OTC Electrical Stimulator is manufactured by Hivox Biotek, Inc..

What is the FDA product code for HIVOX OTC Electrical Stimulator?

The FDA product code for HIVOX OTC Electrical Stimulator is NUH.

Related Clinical Trials

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Other Devices by Hivox Biotek, Inc.

K171803HIVOX OTC Electrical Stimulator K192264HIVOX Spopad EMS SP-911, SP-921 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 K232675Heating Tens, FT-615

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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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