Skip to content

Cutaneous Ground Electrode

by Neuro Supplies, Inc.

510(k) K991770

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 NumberK991770 Date18 Aug 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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 882.1320
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Cutaneous Ground Electrode is a device used as a recording electrode during electromyographic recordings. It is designed for non-invasive use as an active or reference electrode. The device is used in conjunction with electromyography equipment to record electrical activity in the body.

The Cutaneous Ground Electrode is supplied by Neuro Supplies, Inc. and has been cleared under the FDA 510(k) clearance, with the reference number K991770. The device is intended for use in a clinical setting and is subject to the regulations and guidelines set forth by the FDA. The electrode is designed for single-use and is disposable.

Other devices from Neuro Supplies, Inc.

Questions

AI-generated answers, 27 Sep 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 Cutaneous Ground Electrode used for?

    The Cutaneous Ground Electrode is used as a recording electrode during electromyographic recordings to record electrical activity in the body.

  • Is the Cutaneous Ground Electrode reusable?

    No, the Cutaneous Ground Electrode is designed for single-use and is disposable.

  • What type of setting is the Cutaneous Ground Electrode intended for?

    The Cutaneous Ground Electrode is intended for use in a clinical setting.