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POM

Computerized Cognitive Assessment Aid For Concussion

Product code
POM
Device name
Computerized Cognitive Assessment Aid For Concussion
Device class
Class 2
21 CFR
21 CFR 882.1471
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
8

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-02-15.

NumberDecision dateApplicantDevice name
K2417372025-02-15Sway Medical, Inc.Sway System Sports Plus summary
K2316882023-09-16Impact Applications, Inc.ImPACT Version 4 summary
Official FDA classification page: POM
Classification and pathway per current FDA publications. Data from openFDA (CC0).