← Back to catalogue

Neuro Pulse

FDA 510(k)

Class II (US FDA 510(k))

510(k) K841400

by Parker Laboratories, Inc.

Identifiers

510(k) Number
K841400 FDA 510(k)
FDA Product Code
GZJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5890 FDA 510(k)
Regulation Number
882.5890 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Neuro Pulse is a stimulator, nerve, transcutaneous device for pain relief. It is classified under product code GZJ and is intended for use in neurology applications.

The device is supplied as a Class II medical device with FDA 510K clearance (K841400) received on 1984-04-03 and decided as substantially equivalent on 1984-06-15. It is manufactured by Parker Laboratories, Inc. and is not third party reviewed.

Frequently asked questions

What is the Neuro Pulse device used for?

The Neuro Pulse is a transcutaneous nerve stimulator device designed for pain relief in neurology applications. It delivers electrical stimulation through the skin to help manage pain conditions.

How is the Neuro Pulse supplied and what are its specifications?

The Neuro Pulse is supplied as a Class II medical device with FDA 510K clearance (K841400). It is manufactured by Parker Laboratories, Inc. and is not third party reviewed. The device is intended for neurology applications and is classified under product code GZJ.

Is the Neuro Pulse a single-use or reusable device?

The device data does not specify whether the Neuro Pulse is single-use or reusable. For information on device reusability, please consult the manufacturer's instructions or contact Parker Laboratories, Inc. directly.

What is the regulatory status of the Neuro Pulse device?

The Neuro Pulse has FDA 510K clearance (K841400) received on April 3, 1984, and was decided as substantially equivalent on June 15, 1984. It is classified under product code GZJ and is manufactured by Parker Laboratories, Inc.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Parker Laboratories | Ultrasound Gels & Medical Products, NEURO PULSE 510 (k) K841400 - FDA.report, PDF K841400 - Neuro Pulse, NeuroPULSE, Neuro Pulse Pro Supplement EXPOSED - Scam Ads & Red Flags

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Parker Laboratories, Inc.

Sources (1)

  • FDA 510(k) K841400 24 fields · synced Sep 26, 2026