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T.E.N.S. Single-Use Electrode

FDA 510(k)

Class II (US FDA 510(k))

510(k) K790850

by 3m Company

Identifiers

510(k) Number
K790850 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 T.E.N.S. Single-Use Electrode is a Cutaneous Electrode (product code GXY) designed for transcutaneous electrical nerve stimulation (TENS). It delivers low-voltage electrical impulses to the skin surface, intended for pain management and neuromodulation in neurology applications.

This device is supplied as a single-use, non-sterile electrode intended for reusable TENS units. It is classified under FDA product code GXY, with a clearance type of Traditional and a decision of Substantially Equivalent (SESE). Authorized under FDA 510(k) clearance K790850, it was reviewed by the Neurology Advisory Committee in 1979.

Frequently asked questions

What is the T.E.N.S. Single-Use Electrode primarily used for in clinical settings?

The T.E.N.S. Single-Use Electrode is designed for transcutaneous electrical nerve stimulation (TENS), a technique that delivers low-voltage electrical impulses to the skin to manage pain and modulate nerve activity. It is specifically indicated for neurology applications, such as chronic pain relief or neuromodulation, though its use depends on the clinician’s discretion and the TENS unit’s programming.

Is this electrode meant for single-use or reusable applications, and how does that affect its sterility?

The T.E.N.S. Single-Use Electrode is explicitly labeled for single-use only and is non-sterile. This means it should not be reused after one application, as reuse could compromise hygiene and performance. The non-sterile classification aligns with its intended use on reusable TENS units, where the device itself (not the electrode) is the primary reusable component.

What sizes or models are available for the T.E.N.S. Single-Use Electrode, and how should they be stored?

The provided data does not specify exact sizes or model variants (e.g., small, large, or pediatric), but the electrode is designed for cutaneous (skin-surface) application in TENS therapy. Storage instructions are not detailed, but single-use electrodes like this are typically stored in a cool, dry place, protected from direct sunlight or extreme temperatures, until use. Always check the packaging for manufacturer-specific storage guidance.

How was the FDA clearance for this device determined, and what role did the Neurology Advisory Committee play?

The T.E.N.S. Single-Use Electrode received FDA 510(k) clearance (K790850) under the Traditional pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. The Neurology Advisory Committee (reviewed in 1979) provided advisory input during the 1979 submission, though the committee’s role is administrative—it does not define clinical indications. The clearance reflects that the device meets regulatory standards for transcutaneous electrical nerve stimulation (TENS) electrodes as classified under product code GXY.

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. Sources consulted: T.E.N.S.* SINGLE-USE ELECTRODE (K790850) - FDA 510 (k), T.E.N.S.* SINGLE-USE ELECTRODE (K790850) — FDA 510(k) | Innolitics, T.e.n.s.* Single-use Electrode 510 (k) K790850 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
3m Company

Sources (1)

  • FDA 510(k) K790850 24 fields · synced Sep 19, 2026