Data / Medical devices / Computerized Cognitive Assessment Aid, Exempt / United States
FDA-registered makers of Computerized Cognitive Assessment Aid, Exempt in the United States: 22 establishments
22 establishments in the United States are registered with the FDA to make Computerized Cognitive Assessment Aid, Exempt (product code PTY). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Computerized Cognitive Assessment Aid, Exempt
- Product code
- PTY
- Country
- United States
Makers of Computerized Cognitive Assessment Aid, Exempt in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bertec Corp. | Columbus, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Braincheck, Inc. | Austin, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioventus LLC | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CNS Vital Signs | Morrisville, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cognifit | San Francisco, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cognivue, Inc. | Victor, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cogstate Ltd | New Haven, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hhitt, Inc. | San Francisco, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Impact Applications, Inc. | Itasca, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linus Health, Inc. | Boston, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mindtrace Technologies, Inc. | Pittsburgh, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neurotone Ai, Inc | Gainesville, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neurotrack Technologies | Redwood City, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neurotrax Corp | Naples, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Posit Science | San Francisco, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spark Neuro, Inc. | New York, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sportgait, Inc. | Wilmington, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sway Medical, Inc. | Tulsa, OK, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Videra Health | Orem, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Virgo Usa R&D Corp | Great Neck, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vista Lifesciences, Inc. | Englewood, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vistim Labs Inc. | Claymont, DE, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.