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Quantum 84

by Cadwell Laboratories, Inc.

510(k) K844707

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 NumberK844707 Date21 May 1985ClearedStatusActive

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  • Withdrawn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
GWF
Device Class
Class II
Regulation
21 CFR Part 882.1870
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 Quantum 84 is an Electrical Stimulator designed for evoked response testing, classified under the FDA’s Electrical Stimulator category. It delivers precise electrical stimulation to assess neural pathways and muscle responses, supporting diagnostic evaluations in neurology. The device integrates multiple microprocessors to enhance accuracy and efficiency in automated result calculations and streamlined testing workflows.

This reusable, non-sterile device is intended for use in clinical electrophysiology settings, including hospitals and diagnostic laboratories. It operates under FDA 510(k) clearance (K844707) and is regulated under the classification of Class II (GWF product code). The Quantum 84 features customizable test protocols and single-button operation, facilitating ease of use for clinicians performing electromyography (EMG), nerve conduction studies (NCS), and evoked potential (EP) assessments.

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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 Quantum 84 Electrical Stimulator used for?

    The Quantum 84 is designed for evoked response testing in neurology. It delivers precise electrical stimulation to assess neural pathways and muscle responses, supporting diagnostic evaluations through electromyography (EMG), nerve conduction studies (NCS), and evoked potential (EP) assessments.

  • Is the Quantum 84 a single-use or reusable device?

    The Quantum 84 is a reusable device that is non-sterile. It is intended for repeated use in clinical electrophysiology settings, including hospitals and diagnostic laboratories, where it can be utilized for various diagnostic procedures over time.

  • What are the key features of the Quantum 84?

    The Quantum 84 integrates multiple microprocessors for enhanced accuracy and efficiency in automated result calculations. It features customizable test protocols and single-button operation, facilitating ease of use for clinicians performing various electrophysiological assessments.

  • What is the regulatory status of the Quantum 84?

    The Quantum 84 operates under FDA 510(k) clearance (K844707) and is regulated under Class II (GWF product code). It has been determined to be substantially equivalent to other devices in its classification for evoked response testing in neurology.