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Neuro Scan Medical Ststems, Model Medicor 8

by Neurosoft, Inc. 510(k)

Active United States

510(k) K001692

Overview

The Neuro Scan Medical Systems, Model Medicor 8 is a nerve conduction velocity measurement device that measures nerve conduction time by applying a stimulus, typically to a patient's peripheral nerve. It includes a stimulator and electronic processing equipment for measuring and displaying nerve conduction time.

The device is classified as a Class II medical device under FDA regulation 882.1550 and has received 510(k) clearance (K001692) from Neurosoft, Inc. It is intended for use in neurology and is not specified as single-use, reusable, sterile, or MRI-safe in the provided data.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001692 Date24 Nov 2000ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
JXE
Device Class
Class II
Regulation
21 CFR Part 882.1550
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Neurosoft, Ltd.

Questions

  • What is the Medicor 8 used for?

    The Medicor 8 is a nerve conduction velocity measurement device. It measures nerve conduction time by applying a stimulus, typically to a patient's peripheral nerve, to assess nerve function.

  • Is the Medicor 8 a single-use device?

    The provided data does not specify if the Medicor 8 is single-use or reusable. It is intended for use in neurology and is not specified as single-use, reusable, sterile, or MRI-safe.

  • How is the Medicor 8 classified by the FDA?

    The Medicor 8 is classified as a Class II medical device under FDA regulation 882.1550 and has received 510(k) clearance (K001692).

  • What are the key components of the Medicor 8 system?

    The Medicor 8 system includes a stimulator and electronic processing equipment. These components are used to measure and display nerve conduction time.