Skip to content

Sensory Nerve Conduction Velocity Testing Unit

by Occupational Preventive Diagnostics, Inc.

510(k) K904165

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 NumberK904165 Date28 May 1991ClearedStatusActive

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  • Withdrawn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
JXE
Device Class
Class II
Regulation
21 CFR Part 882.1550
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.

The Sensory Nerve Conduction Velocity Testing Unit is a medical device used for measuring nerve conduction velocity in sensory nerves. It is classified under device class 2 and is intended for neurology applications. The device helps in assessing nerve function by measuring the speed at which electrical signals travel through sensory nerves.

This device is supplied by Occupational Preventive Diagnostics, Inc. and is regulated under FDA 510(k) clearance K904165, with a decision date of May 28, 1991. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided. The device has been cleared as substantially equivalent under product code JXE and regulation number 882.1550.

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 Sensory Nerve Conduction Velocity Testing Unit used for?

    This device is used for measuring nerve conduction velocity in sensory nerves, helping clinicians assess nerve function by determining the speed at which electrical signals travel through sensory nerves in neurology applications.

  • What is the regulatory status of this device?

    The Sensory Nerve Conduction Velocity Testing Unit is regulated under FDA 510(k) clearance K904165 with a decision date of May 28, 1991. It is classified as device class 2 and has been cleared as substantially equivalent under product code JXE and regulation number 882.1550.

  • Is this device single-use or reusable?

    The device data does not specify whether the Sensory Nerve Conduction Velocity Testing Unit is designed for single-use or reusable applications. This information would need to be obtained directly from the manufacturer, Occupational Preventive Diagnostics, Inc.

  • What are the storage requirements for this device?

    No information regarding storage conditions for the Sensory Nerve Conduction Velocity Testing Unit is provided in the device data. Users should consult the manufacturer's instructions for proper storage requirements.