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TENS Conductive Media Pad

by Creative Design Systems, Inc.

510(k) K904889

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK904889 Date14 May 1991ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GYB
Device Class
Class II
Regulation
21 CFR Part 882.1275
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The TENS Conductive Media Pad is an electroconductive medium designed for use with transcutaneous electrical nerve stimulation (TENS) devices. It serves as a conductive interface between the electrode and the skin, reducing impedance to facilitate effective electrical current transmission during pain management or neuromodulation therapies.

These pads are supplied as single-use, non-sterile disposable items and are classified under FDA regulation 21 CFR 882.1275. They are intended for use in clinical settings where TENS therapy is administered, with no specific MRI safety considerations noted. The product holds an FDA 510(k) clearance (K904889) under the product code GYB, granted in 1991, and is intended for neurology applications.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the TENS Conductive Media Pad used for?

    The TENS Conductive Media Pad is designed as an electroconductive interface for transcutaneous electrical nerve stimulation (TENS) devices. It improves electrical current transmission between the electrode and skin, enhancing the effectiveness of TENS therapy for pain management or neuromodulation in clinical settings.

  • Are these pads single-use or reusable?

    These pads are supplied as single-use, disposable items. This design ensures hygiene and reduces the risk of cross-contamination between patients, which is particularly important in clinical environments where TENS therapy is administered.

  • Are the TENS Conductive Media Pads sterile?

    No, these pads are non-sterile. They are intended for use in clinical settings where standard infection control practices are followed, such as proper hand hygiene and surface disinfection, to maintain patient safety.

  • What regulatory approval does this device hold?

    The TENS Conductive Media Pad holds an FDA 510(k) clearance (K904889) under product code GYB, granted in 1991. It is classified under FDA regulation 21 CFR 882.1275 and is intended for neurology applications.

  • How should these pads be stored?

    Since these pads are single-use and non-sterile, they should be stored in a clean, dry environment, protected from moisture and direct sunlight. Ensure the packaging remains intact until use to maintain their conductive properties and prevent contamination.