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ImPACT Quick Test

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K170551

by ImPACT Applications, Inc.

Identifiers

510(k) Number
K170551 FDA 510(k)
FDA Product Code
POM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1471 FDA 510(k)
Regulation Number
882.1471 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ImPACT Quick Test is a Computerized Cognitive Assessment Aid for Concussion, designed to evaluate cognitive function in patients suspected of having a concussion or mild traumatic brain injury. It provides standardized assessments of verbal and visual memory, processing speed, reaction time, and other neurocognitive domains to aid in clinical decision-making and monitoring of recovery progress.

This device is supplied as a software application for use on compatible computers and is intended for single-use per patient assessment. It operates in clinical settings such as emergency departments, sports medicine facilities, and neurology clinics, with no sterility requirements. The ImPACT Quick Test holds FDA 510(k) clearance and is classified under EU MDR, adhering to regulatory standards for cognitive assessment tools in concussion management.

Frequently asked questions

How does the ImPACT Quick Test help clinicians assess concussion or mild traumatic brain injury in patients?

The ImPACT Quick Test is a software-based tool designed to evaluate cognitive function through standardized assessments of verbal and visual memory, processing speed, reaction time, and other neurocognitive domains. By providing objective measurements in these areas, it aids clinicians in making informed decisions about concussion diagnosis and monitoring recovery progress in clinical settings like emergency departments or sports medicine facilities.

Is the ImPACT Quick Test intended for repeated use with the same patient, or is it meant for single assessments?

The ImPACT Quick Test is supplied as a software application intended for single-use per patient assessment. This means each evaluation is conducted on a one-time basis for an individual patient, allowing for fresh baseline or follow-up comparisons as needed during concussion management.

What types of clinical environments is the ImPACT Quick Test approved for use in?

The ImPACT Quick Test is approved for use in clinical settings such as emergency departments, sports medicine facilities, and neurology clinics. Its design supports cognitive assessments in these environments, where concussion or mild traumatic brain injury evaluations are commonly conducted.

Does the ImPACT Quick Test require any special handling or storage conditions?

Since the ImPACT Quick Test is a software application running on compatible computers, there are no sterility requirements or physical storage conditions to consider. However, the device should be installed on properly maintained hardware to ensure accurate and reliable cognitive assessments.

What regulatory pathways has the ImPACT Quick Test followed for approval?

The ImPACT Quick Test has obtained FDA 510(k) clearance, demonstrating it is substantially equivalent to a legally marketed device. Additionally, it complies with the EU Medical Device Regulation (MDR), adhering to the regulatory standards for cognitive assessment tools used in concussion management.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
ImPACT Applications, Inc.

Sources (2)

  • FDA 510(k) K170551 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 28, 2026