POM — Computerized Cognitive Assessment Aid For Concussion Class II
FDA product code POM covers "Computerized Cognitive Assessment Aid For Concussion", a Class II medical device regulated under 21 CFR 882.1471. Submissions are reviewed by the Neurology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- POM
- Device Class
- Class II
- Regulation Number
- 882.1471
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
For use as an assessment aid in the management of concussion.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241737 | Sway Medical | Sway System Sports Plus | Feb 15, 2025 |
| K231688 | Impact Applications | ImPACT Version 4 | Sep 16, 2023 |
| K201376 | Vista Lifesciences | ANAM Test System | Mar 25, 2021 |
| K202485 | Impact Applications | ImPACT Version 4 | Dec 25, 2020 |
| K181223 | Impact Applications | ImPACT | Oct 20, 2018 |
| K170551 | Impact Applications | ImPACT Quick Test | Jun 21, 2017 |
| K170209 | Impact Applications | ImPACT | Feb 23, 2017 |
| DEN150037 | Impact Applications | ImPACT Computerized Neurocognitive Concussion Management Aid | Aug 22, 2016 |