Transcoutaneous Electro-Neuro Stimulator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K884972 ↗

FDA Product Code

GZJ

Device Class

Class II

Regulation

21 CFR Part 882.5890

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Spirovision

  Class II

  FDA 510(k) K864885 Active Cleared 15 Jan 1987

• Carbon Electrode

  Class II

  FDA 510(k) K872044 Active Cleared 16 Jul 1987

• Selector Sl 01

  Class II

  FDA 510(k) K933220 Active Cleared 24 Nov 1993

• Conductivity Gel

  Class II

  FDA 510(k) K871913 Active Cleared 15 Jul 1987

• Tens Device for Relief of Chronic Pain

  Class II

  FDA 510(k) K864114 Active Cleared 1 Apr 1987

• St-460 Spiro Analyzer Spirometer

  Class II

  FDA 510(k) K852308 Active Cleared 24 Jun 1985

See all devices from Futuremed Div. of Future Impex Corp. →

• What types of chronic pain conditions is this device intended to help manage, and how does it work?

  This Transcutaneous Electro-Neuro Stimulator (TENS) device is designed for non-invasive pain management by delivering low-voltage electrical impulses through surface electrodes. It modulates pain signals in peripheral nerves to provide relief for chronic pain conditions, though the exact conditions aren’t specified beyond its general indication for pain management. It’s intended for clinical use under professional supervision, offering an alternative for patients seeking non-pharmacological or minimally invasive options.

• Is this device single-use or reusable, and what does that mean for maintenance and cleaning?

  The device is explicitly labeled as a reusable medical instrument, meaning it is intended for repeated use in clinical settings. Since it is not implanted or introduced into sterile body cavities, it does not require sterile packaging or sterilization before each use. However, proper cleaning and maintenance between uses are essential to ensure safety and functionality, as outlined in the manufacturer’s instructions (not detailed here).

• How is this device regulated, and what does the FDA’s 510(k) clearance mean for its use?

  This device holds an FDA 510(k) clearance (K884972), meaning it has been determined to be substantially equivalent to a legally marketed device already on the market. This clearance indicates that the device meets regulatory standards for safety and effectiveness as defined by the FDA’s Neurology advisory committee (NE). Clinicians can rely on this classification to confirm the device’s compliance with U.S. medical device regulations for its intended use.

• Are there different sizes or models available for this device, or is it a one-size-fits-all solution?

  The provided data does not mention any specific size variations or distinct models for this Transcutaneous Electro-Neuro Stimulator. It is described as a general-purpose TENS device, implying a standardized design for broad clinical use. If customization is needed for specific patient anatomies or pain sites, additional accessories (like electrode pads) may be available, but those details are not included in the current documentation.

• What should clinicians consider when storing this device, and are there any special handling requirements?

  Since the device is reusable and not sterile, storage should follow general guidelines for reusable medical instruments to prevent contamination or damage. The manufacturer’s instructions (not provided here) likely outline proper storage conditions, such as keeping it in a clean, dry environment away from extreme temperatures or moisture. Unlike single-use or sterile devices, it does not require refrigeration or specialized packaging, but routine maintenance (e.g., cleaning between uses) is critical to ensure reliability and safety.