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FDA 510(k)

Transcutaneous Electronic Nerve Stimulator

K-Number: K200237 · 2020-10-19

ApplicantShenzhen Kentro Medical Electronics Co., Ltd.
Decision Date2020-10-19
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Transcutaneous Electronic Nerve Stimulator is a medical device manufactured by Shenzhen Kentro Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-10-19 under approval number K200237. 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 Electronic Nerve Stimulator?

Transcutaneous Electronic Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2020-10-19. It is manufactured by Shenzhen Kentro Medical Electronics Co., Ltd.. The 510(k) number is K200237.

When was Transcutaneous Electronic Nerve Stimulator approved by the FDA?

Transcutaneous Electronic Nerve Stimulator received FDA 510(k) clearance on 2020-10-19, under approval number K200237.

What company makes Transcutaneous Electronic Nerve Stimulator?

Transcutaneous Electronic Nerve Stimulator is manufactured by Shenzhen Kentro Medical Electronics Co., Ltd..

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

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

Related Clinical Trials

NCT07517172 Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study 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 NCT06614933 How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation? COMPLETED

Other Devices by Shenzhen Kentro Medical Electronics Co., Ltd.

K170205Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 K181728Muscle Trainer K183288Transcutaneous Electrical Nerve Stimulator K191982Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) K200177Low-frequency Multi-function physiotherapy instrument K220998Transcutaneous Electrical Nerve Stimulator, Model: KTR-405

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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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