POM
8 FDA 510(k) clearances · Product code
165 daysmedian time to decision
377 days90th percentile
8clearances measured
FDA profile
- Official device name
- Computerized Cognitive Assessment Aid For Concussion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1471
- Medical specialty
- Neurology
- FDA definition
- For use as an assessment aid in the management of concussion.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Sway System Sports Plus (K241737) | Sway Medical, Inc. | 2025-02-15 |
| ImPACT Version 4 (K231688) | Impact Applications, Inc. | 2023-09-16 |
| ANAM Test System (K201376) | Vista Lifesciences, Inc. | 2021-03-25 |
| ImPACT Version 4 (K202485) | Impact Applications, Inc. | 2020-12-25 |
| ImPACT (K181223) | Impact Applications, Inc. | 2018-10-20 |
| ImPACT Quick Test (K170551) | Impact Applications, Inc. | 2017-06-21 |
| ImPACT (K170209) | Impact Applications, Inc. | 2017-02-23 |
| ImPACT Computerized Neurocognitive Concussion Management Aid (DEN150037) | Impact Applications, Inc. | 2016-08-22 |
Track POM automatically
Every clearance here is in the API, with alerts when new ones post.