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FDA 510(k)

Transcutaneous Electrical Nerve Stimulator

K-Number: K183288 · 2019-07-30

ApplicantShenzhen Kentro Medical Electronics Co., Ltd.
Decision Date2019-07-30
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Transcutaneous Electrical Nerve Stimulator is a medical device manufactured by Shenzhen Kentro Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-07-30 under approval number K183288. 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 2019-07-30. It is manufactured by Shenzhen Kentro Medical Electronics Co., Ltd.. The 510(k) number is K183288.

When was Transcutaneous Electrical Nerve Stimulator approved by the FDA?

Transcutaneous Electrical Nerve Stimulator received FDA 510(k) clearance on 2019-07-30, under approval number K183288.

What company makes Transcutaneous Electrical Nerve Stimulator?

Transcutaneous Electrical Nerve Stimulator is manufactured by Shenzhen Kentro Medical Electronics 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

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

K170205Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 K181728Muscle Trainer K200237Transcutaneous Electronic 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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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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