Data / Medical devices / Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid (QEA): 3 FDA-registered makers in 1 country
3 establishments in 1 country are registered with the FDA to make Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid (product code QEA, Class 2, 21 CFR 882.1455). 3 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on June 5, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QEA
- Device class
- 2
- Regulation
- 882.1455
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
Makers of Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
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 |
|---|---|---|---|---|---|---|---|---|
| Oculogica Inc. | New Richmond, WI, United States | Specification developer | 5 | April 4, 2025 | 0 | 1 | 0 | api.fda.gov |
| Neurosync, Inc. | Holliston, MA, United States | Manufacturer | 1 | October 2, 2021 | 0 | 1 | 0 | api.fda.gov |
| Oculogica - Backburner Labs Inc. | Saint Paul, MN, United States | Manufacturer | 1 | June 5, 2026 | 0 | 0 | 0 | api.fda.gov |
Updated June 5, 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.