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Neurocomp

by Neurocybernetics

510(k) K993654

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 NumberK993654 Date27 Jan 2000ClearedStatusActive

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  • Withdrawn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
HCC
Device Class
Class II
Regulation
21 CFR Part 882.5050
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Neurocomp is a biofeedback device classified under neurology. It is designed to monitor and provide feedback on physiological processes.

This device is regulated as a Class 2 medical device under FDA 510(k) clearance K993654. It is manufactured by Neurocybernetics and is categorized under product code HCC.

Questions

AI-generated answers, 26 Sep 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 primary function of the Neurocomp?

    The Neurocomp is a biofeedback device classified under neurology. It is specifically designed to monitor physiological processes and provide feedback to the user based on those measurements.

  • How is the Neurocomp regulated?

    The Neurocomp is regulated as a Class 2 medical device. It received FDA 510(k) clearance under the number K993654, which indicates it was found to be substantially equivalent to other legally marketed devices.

  • Which medical specialty is this device associated with?

    The Neurocomp is categorized under the neurology medical specialty, as indicated by its product code HCC and its review by the neurology advisory committee.