Skip to content

EMG/NCV & Evoked Response, Design W/

by Neurodiagnostics, Inc.

510(k) K843253

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 NumberK843253 Date20 Nov 1984ClearedStatusActive

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  • Withdrawn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
GWF
Device Class
Class II
Regulation
21 CFR Part 882.1870
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.

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response. It is classified as a Stimulator, Electrical, Evoked Response under regulation number 882.1870 and falls within the Neurology medical specialty.

The device received FDA 510(k) clearance under K843253 with a decision of Substantially Equivalent (SESE) on 1984-11-20. It is a class II device with product code GWF, reviewed by the Neurology advisory committee, and was not third-party reviewed.

Other devices from Neurodiagnostics, Inc.

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 EMG/NCV & Evoked Response, Design W/ used for?

    This device is used to apply an electrical stimulus to a patient through skin electrodes to measure evoked responses, which helps assess neurological function by recording the body's response to stimulation.

  • How is the EMG/NCV & Evoked Response, Design W/ supplied and is it sterile or single-use?

    The device data does not specify whether the stimulator is supplied sterile, single-use, or reusable; therefore, no conclusion can be drawn about its sterility or usage lifecycle from the provided information.

  • What regulatory pathway was used for the EMG/NCV & Evoked Response, Design W/ and what is its classification?

    The device received FDA 510(k) clearance under K843253 on 1984-11-20, was found substantially equivalent, and is classified as a Class II device with product code GWF under regulation 882.1870.