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FDA 510(k)

HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2

K-Number: K203574 · 2021-03-10

ApplicantHivox Biotek, Inc.
Decision Date2021-03-10
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 is a medical device manufactured by Hivox Biotek, Inc.. It received FDA 510(k) clearance on 2021-03-10 under approval number K203574. 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, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2?

HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 is a medical device that received FDA 510(k) clearance on 2021-03-10. It is manufactured by Hivox Biotek, Inc.. The 510(k) number is K203574.

When was HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 approved by the FDA?

HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 received FDA 510(k) clearance on 2021-03-10, under approval number K203574.

What company makes HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2?

HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 is manufactured by Hivox Biotek, Inc..

What is the FDA product code for HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2?

The FDA product code for HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 is NUH.

Related Clinical Trials

NCT07187388 Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease. RECRUITING NCT05664854 Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve RECRUITING NCT07569705 Effect of Transcutaneous Electrical Nerve Stimulation on PODD in Bariatric Surgery Patients RECRUITING NCT06811545 Evaluating the Effects of an Electrical Stimulator on Improving the Walking Ability of Children With Cerebral Palsy NOT_YET_RECRUITING NCT07574268 Efficacy of Transcutaneous Electrical Neural Stimulation and Tadalafil in Men With Erectile Dysfunction: A Randomized, Double-Blind, Bi-centric, Placebo- and Sham-Controlled Trial COMPLETED NCT07531238 Transcranial Temporal Interference Stimulation (tTIS) To Modulate Essential Tremor NOT_YET_RECRUITING

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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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