TTS2800

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

510(k) Number

K895161 ↗

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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• Endomed CV405

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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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  FDA 510(k) K915864 Active Cleared 21 Jul 1993

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  FDA 510(k) K896817 Active Cleared 18 Jan 1991

See all devices from Henley Intl. →

• What is the TTS2800 used for?

  The TTS2800 is a transcutaneous nerve stimulator designed to provide pain relief through electrical stimulation of peripheral nerves. It modulates pain signals by delivering controlled impulses via surface electrodes, making it suitable for managing acute or chronic pain conditions without penetrating the skin. This non-invasive approach aligns with transcutaneous electrical nerve stimulation (TENS) principles.

• Is the TTS2800 reusable or single-use?

  The TTS2800 is a reusable medical instrument intended for clinical settings like outpatient clinics or physician offices. Since it is not single-use, proper cleaning and maintenance are required between uses to ensure hygiene and functionality. The manufacturer provides guidelines for upkeep in the user manual.

• Does the TTS2800 require sterilization between uses?

  No, the TTS2800 does not require sterilization between uses. However, it must be cleaned and maintained according to the manufacturer’s instructions to uphold performance and hygiene standards. This distinction is important for clinical environments where reusable devices are used repeatedly.

• What regulatory approval does the TTS2800 hold?

  The TTS2800 is authorized under FDA 510(k) clearance with the reference number K895161. It falls under Class II regulatory controls and is classified under product code GZJ. The device was determined substantially equivalent to a predicate through a traditional review process by the Neurology Advisory Committee.

• How should the TTS2800 be stored?

  Storage conditions for the TTS2800 are detailed in the accompanying user manual. While the manual specifies operational parameters, it is critical to follow these guidelines to preserve the device’s functionality and longevity. Proper storage helps maintain performance and ensures the device remains ready for clinical use.