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Tanyx

by Medecell Us, Inc.

510(k) K123866

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123866 Date13 Sep 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NUH
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Tanyx is a Transcutaneous Nerve Stimulator, classified as a Stimulator, Nerve, Transcutaneous, Over-The-Counter device. It is a medical device used for nerve stimulation. The device is associated with the product code NUH and is regulated under the classification name Stimulator, Nerve, Transcutaneous, Over-the-counter. The Tanyx is related to the medical specialty of Neurology.

The Tanyx is supplied by Medecell Us, Inc. and has been assigned the k number K123866. The device was found to be Substantially Equivalent and was cleared on September 13, 2013. The Tanyx is associated with the FDA 510K authorization.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Tanyx used for?

    The Tanyx is used for nerve stimulation, specifically as a Transcutaneous Nerve Stimulator, and is related to the medical specialty of Neurology.

  • How is the Tanyx supplied?

    The Tanyx is supplied by Medecell Us, Inc., and has been assigned the k number K123866.

  • Is the Tanyx a single-use or reusable device?

    The device description does not explicitly state whether the Tanyx is single-use or reusable, but it is classified as an Over-The-Counter device.

  • What is the regulatory status of the Tanyx?

    The Tanyx was found to be Substantially Equivalent and was cleared on September 13, 2013, under the FDA 510K authorization.