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TENS Electrodes

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K160081

by Cathay Manufacturing Corp.

Identifiers

510(k) Number
K160081 FDA 510(k)
FDA Product Code
GXY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1320 FDA 510(k)
Regulation Number
882.1320 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TENS Electrodes are a type of Transcutaneous Electrical Nerve Stimulation (TENS) Electrode designed to deliver low-voltage electrical currents for pain management. These electrodes are applied to the skin to modulate nerve signals and provide relief for acute or chronic pain conditions, adhering to the principles of neuromodulation therapy.

These electrodes are supplied as single-use, sterile adhesive pads intended for external application. They are classified under the GXY product code and are regulated under FDA 510K and MDR compliance. Each electrode is pre-packaged for clinical use, ensuring compatibility with standard TENS units and adherence to regulatory standards for electrical safety and medical device performance.

Frequently asked questions

Are these TENS electrodes meant for repeated use, or are they designed as single-use items?

These TENS electrodes are explicitly designed as single-use items. Each electrode is pre-packaged and sterile, ensuring clinical safety and hygiene for one-time application only. This aligns with standard medical device practices for external pain management electrodes to prevent cross-contamination and maintain regulatory compliance.

What types of pain conditions can these electrodes be used for, and how do they work?

These TENS electrodes are intended for acute or chronic pain management by delivering low-voltage electrical currents via transcutaneous electrical nerve stimulation (TENS). They work by modulating nerve signals to interfere with pain transmission, providing relief for conditions where neuromodulation therapy is clinically appropriate. The electrodes adhere to the skin and are compatible with standard TENS units.

How are these electrodes packaged, and what should I consider when storing them?

The TENS electrodes are pre-packaged individually for clinical use, ensuring sterility and readiness for immediate application. Storage should follow standard medical device guidelines: keep them in a cool, dry place, away from direct sunlight or extreme temperatures. Avoid opening the packaging until use to maintain sterility and functionality.

Are these electrodes compatible with all TENS units, or do they require a specific model?

These electrodes are designed for compatibility with standard TENS units commonly used in clinical and home settings. While they are not tied to a specific brand or model, it’s always best to verify compatibility with your particular device to ensure optimal performance and electrical safety.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cathay Manufacturing Corp.

Sources (2)

  • FDA 510(k) K160081 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026