POM — Computerized Cognitive Assessment Aid For Concussion Class II
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 | February 15, 2025 |
| K231688 | impact applications | ImPACT Version 4 | September 16, 2023 |
| K201376 | vista lifesciences | ANAM Test System | March 25, 2021 |
| K202485 | impact applications | ImPACT Version 4 | December 25, 2020 |
| K181223 | impact applications | ImPACT | October 20, 2018 |
| K170551 | impact applications | ImPACT Quick Test | June 21, 2017 |
| K170209 | impact applications | ImPACT | February 23, 2017 |
| DEN150037 | impact applications | ImPACT Computerized Neurocognitive Concussion Management Aid | August 22, 2016 |