510(k) K231688
- Device
- ImPACT Version 4
- Applicant
- Impact Applications, Inc.
- 510(k) number
- K231688
- Product code
- POM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-16
- Date received
- 2023-06-09
- Regulation
- 882.1471
- Classification name
- Computerized Cognitive Assessment Aid For Concussion
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Michael Zagorski
- Address
- 2140 Norcor Ave., Suite 115 Coralville IA US 52241 52241
FDA Registration Numbers#
- 3012102743
- 3010325634
- 3011279934
Source Documents#
Other 510(k) Records For Product Code POM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241737 | Sway System Sports Plus | Sway Medical, Inc. | 2025-02-15 |
| K201376 | ANAM Test System | Vista Lifesciences, Inc. | 2021-03-25 |
| K202485 | ImPACT Version 4 | Impact Applications, Inc. | 2020-12-25 |
| K181223 | ImPACT | Impact Applications, Inc. | 2018-10-20 |
| K170551 | ImPACT Quick Test | Impact Applications, Inc. | 2017-06-21 |
| K170209 | ImPACT | Impact Applications, Inc. | 2017-02-23 |
| DEN150037 | ImPACT Computerized Neurocognitive Concussion Management Aid | Impact Applications, Inc. | 2016-08-22 |