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NDI-IKE EMG

by Neurodiagnostics, Inc.

510(k) K801670

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801670 Date4 Aug 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
GWK
Device Class
Class II
Regulation
21 CFR Part 882.1845
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 NDI-IKE EMG is a Physiological Signal Conditioner, designed to amplify, filter, and process electromyographic (EMG) signals for diagnostic evaluation. It falls under the FDA classification of Class II devices, intended for use in neurological assessments to measure muscle and nerve function.

This device is supplied as a reusable medical instrument, intended for use in clinical settings such as neurology departments or electrodiagnostic laboratories. It operates under standard electrical safety standards and is regulated under FDA 510(k) clearance (K801670), with no specific MRI safety restrictions noted. Storage and handling follow standard medical device protocols for reusable equipment.

Other devices from Neurodiagnostics, Inc.