Computerized Cognitive Assessment Aid For Concussion
The Computerized Cognitive Assessment Aid For Concussion (product code POM) is a Class 2 neurology device intended for use as an assessment aid in the management of concussion, regulated under 882.1471. It requires 510(k) clearance and falls within the neurology medical specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- POM
- Device Class
- FDA class 2
- Regulation Number
- 882.1471
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
For use as an assessment aid in the management of concussion.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241737 | Sway System Sports Plus | Feb 15, 2025 | Substantially Equivalent | Sway Medical, Inc. |
| K231688 | ImPACT Version 4 | Sep 16, 2023 | Substantially Equivalent | Impact Applications, Inc. |
| K201376 | ANAM Test System | Mar 25, 2021 | Substantially Equivalent | Vista Lifesciences, Inc. |
| K202485 | ImPACT Version 4 | Dec 25, 2020 | Substantially Equivalent | Impact Applications, Inc. |
| K181223 | ImPACT | Oct 20, 2018 | Substantially Equivalent | Impact Applications, Inc. |
| K170551 | ImPACT Quick Test | Jun 21, 2017 | Substantially Equivalent | Impact Applications, Inc. |
| K170209 | ImPACT | Feb 23, 2017 | Substantially Equivalent | Impact Applications, Inc. |
| DEN150037 | ImPACT Computerized Neurocognitive Concussion Management Aid | Aug 22, 2016 | Unknown | Impact Applications, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.