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FDA 510(k)

Transcutaneous Electrical Nerve Stimulator

K-Number: K183288 · 2019-07-30

Decision Date2019-07-30
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Transcutaneous Electrical Nerve Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kentro Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-07-30 under 510(k) 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. The listed applicant is Shenzhen Kentro Medical Electronics Co., Ltd.. The 510(k) number is K183288.

When did Transcutaneous Electrical Nerve Stimulator receive FDA 510(k) clearance?

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

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator?

The FDA 510(k) record lists Shenzhen Kentro Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Shenzhen Kentro Medical Electronics Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 10 devices →

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.