Data / Medical devices / Computerized Cognitive Assessment Aid For Concussion
Computerized Cognitive Assessment Aid For Concussion (POM): 3 FDA-registered makers in 1 country
3 establishments in 1 country are registered with the FDA to make Computerized Cognitive Assessment Aid For Concussion (product code POM, Class 2, 21 CFR 882.1471). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on October 18, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- POM
- Device class
- 2
- Regulation
- 882.1471
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
Makers of Computerized Cognitive Assessment Aid For Concussion
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Impact Applications, Inc. | Itasca, IL, United States | Manufacturer | 3 | December 25, 2020 | 0 | 0 | 0 | api.fda.gov |
| Sway Medical, Inc. | Tulsa, OK, United States | Manufacturer | 1 | February 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Vista Lifesciences, Inc. | Englewood, CO, United States | Manufacturer | 1 | March 25, 2021 | 0 | 0 | 0 | api.fda.gov |
Updated October 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.