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FDA 510(k)

Transcutaneous Electrical Nerve Stimulator

K-Number: K210223 · 2021-12-15

ApplicantTop-Rank Health Care Co., Ltd.
Decision Date2021-12-15
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Transcutaneous Electrical Nerve Stimulator is a medical device manufactured by Top-Rank Health Care Co., Ltd.. It received FDA 510(k) clearance on 2021-12-15 under approval number K210223. 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 Transcutaneous Electrical Nerve Stimulator?

Transcutaneous Electrical Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2021-12-15. It is manufactured by Top-Rank Health Care Co., Ltd.. The 510(k) number is K210223.

When was Transcutaneous Electrical Nerve Stimulator approved by the FDA?

Transcutaneous Electrical Nerve Stimulator received FDA 510(k) clearance on 2021-12-15, under approval number K210223.

What company makes Transcutaneous Electrical Nerve Stimulator?

Transcutaneous Electrical Nerve Stimulator is manufactured by Top-Rank Health Care Co., Ltd..

What is the FDA product code for Transcutaneous Electrical Nerve Stimulator?

The FDA product code for Transcutaneous Electrical Nerve Stimulator is NUH.

Related Clinical Trials

NCT07517172 Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT06816004 Noninvasive Vagal Nerve Stimulation ACTIVE_NOT_RECRUITING NCT07614945 Effect of Reflexology on Pain and Sleep Disorders in Females With Fibromyalgia NOT_YET_RECRUITING NCT06127550 taVNS for Letter Learning in Dyslexia SUSPENDED NCT07610655 Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression RECRUITING

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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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