Computerized Cognitive Assessment Aid For Concussion
Regulation 882.1471
1510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in POM
| Company | 510(k)s | Recalls |
|---|---|---|
| Impact Applications, Inc. | 6 | 0 |
| Sway Medical, Inc. | 2 | 0 |
| Vista Lifesciences, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 18, 2026 | K262000 | Sway System (Sports Plus) Sway Medical, Inc. | POM |
| Feb 15, 2025 | K241737 | Sway System Sports Plus Sway Medical, Inc. | POM |
| Sep 16, 2023 | K231688 | ImPACT Version 4 Impact Applications, Inc. | POM |
| Mar 25, 2021 | K201376 | ANAM Test System Vista Lifesciences, Inc. | POM |
| Dec 25, 2020 | K202485 | ImPACT Version 4 Impact Applications, Inc. | POM |
| Oct 20, 2018 | K181223 | ImPACT Impact Applications, Inc. | POM |
| Jun 21, 2017 | K170551 | ImPACT Quick Test Impact Applications, Inc. | POM |
| Feb 23, 2017 | K170209 | ImPACT Impact Applications, Inc. | POM |
| Aug 22, 2016 | DEN150037 | ImPACT Computerized Neurocognitive Concussion Management Aid Impact Applications, Inc. | POM |
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