Neurotens

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

510(k) Number

K896620 ↗

FDA Product Code

GZJ

Device Class

Class II

Regulation

21 CFR Part 882.5890

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K882643 Active Cleared 3 Mar 1989

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  FDA 510(k) K880699 Active Cleared 2 May 1988

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  FDA 510(k) K926313 Active Cleared 4 Feb 1994

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See all devices from Henley Intl. →

• What is the Neurotens device used for?

  Neurotens is a Class II Neurology device designed for neuromodulation applications. It delivers transcutaneous electrical nerve stimulation (TENS) to alleviate pain and manage neurological symptoms through controlled electrical impulses.

• Is the Neurotens device reusable or single-use?

  The Neurotens device is supplied as a reusable medical instrument, meaning it can be used multiple times for neuromodulation therapy in clinical settings.

• What are the regulatory requirements for the Neurotens device?

  The Neurotens device is regulated under the FDA's 510(k) clearance pathway via the Traditional route. It was cleared as substantially equivalent in 1990 with K number K896620.

• Does the Neurotens device require special storage conditions?

  The device data does not specify any special storage requirements for the Neurotens device beyond standard medical instrument storage conditions.

• Is the Neurotens device supplied sterile?

  The regulatory data for the Neurotens device does not indicate any specific sterility requirements, suggesting it may not be supplied sterile or that sterility is not a critical factor for its intended use.