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MSB Electrical Stimulation Electrodes (Disposable) (TENS/FES/NMES)

by Msb, Uk

510(k) K990370

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 NumberK990370 Date12 Apr 1999ClearedStatusActive

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  • Withdrawn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
GXY
FDA applicant
Msb,Uk
Device Class
Class II
Regulation
21 CFR Part 882.1320
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The MSB Electrical Stimulation Electrodes (Disposable) are self-adhesive electrodes designed for transcutaneous electrical nerve stimulation (TENS), functional electrical stimulation (FES), and neuromuscular electrical stimulation (NMES). These electrodes deliver electrical current to patient tissue, facilitating therapeutic interventions for pain management or muscle stimulation when interfaced with external electrical stimulation units.

These disposable electrodes are intended for single-use and are supplied sterile for clinical application. They are classified under FDA product code GXY and were granted 510(k) clearance (K990370) as substantially equivalent to predicate devices. Compliance with regulatory standards ensures safe use in medical settings, though clinical efficacy depends on proper integration with connected stimulation devices.

Questions

AI-generated answers, 19 Sep 2026

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

  • Are these electrodes reusable or meant for single-use, and how does that affect their sterility?

    These electrodes are explicitly designed for single-use only and are supplied sterile for clinical application. This ensures patient safety and hygiene, as reuse could compromise sterility and increase infection risks. The sterile packaging is intended to maintain integrity until first use.

  • What types of electrical stimulation therapies can these electrodes be used for, and how do they work?

    These electrodes are approved for transcutaneous electrical nerve stimulation (TENS), functional electrical stimulation (FES), and neuromuscular electrical stimulation (NMES). They deliver electrical current to patient tissue when connected to an external stimulation device, helping manage pain (TENS) or stimulate muscle activity (FES/NMES) for therapeutic purposes.

  • How are these electrodes supplied, and what should I check before using them?

    The electrodes come pre-sterilized in sterile packaging, ready for immediate clinical use. Before application, verify the packaging remains intact to confirm sterility. They are self-adhesive, so no additional preparation is required beyond ensuring the patient’s skin is clean and dry where placement is intended.

  • What sizes or models are available for these electrodes, and how do I choose the right one?

    The provided data does not specify exact sizes or model variants, but these electrodes are designed for general transcutaneous use across TENS, FES, and NMES applications. Selection should be based on the patient’s anatomy and the stimulation device’s electrode compatibility. Always refer to the manufacturer’s guidelines or the connected device’s specifications for optimal fit and performance.