DeviceClearance

Product code POM— Neurology

ImPACT

Classification name
Computerized Cognitive Assessment Aid For Concussion
Device class
Class 2
Regulation
21 CFR 882.1471
Advisory panel
Neurology
Total cleared
8
First cleared
Most recent

FDA classification definition

“For use as an assessment aid in the management of concussion.”

— U.S. Food and Drug Administration, device classification record for product code POM under 21 CFR 882.1471, via openFDA

Market context for product code POM

FDA has cleared 8 devices under product code POM between 2016 and 2025, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code POM

Recent clearances under product code POM

Data sourced from openFDA. This site is unofficial and independent of the FDA.