510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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POMClass II

Computerized Cognitive Assessment Aid For Concussion

21 CFR 882.1471 / Neurology
FDA source (opens on fda.gov)

POM is the FDA product code for Computerized Cognitive Assessment Aid For Concussion, a class II device type, regulated under 21 CFR 882.1471. FDA's definition for this code reads: "For use as an assessment aid in the management of concussion". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
POM
Device name
Computerized Cognitive Assessment Aid For Concussion
FDA definition
For use as an assessment aid in the management of concussion.
Regulation
21 CFR 882.1471
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code POM

By decision year
8 clearances under product code POM with a decision year between 2016 and 2025, 2017 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code POM by decision year
YearClearances
20161
20172
20181
20201
20211
20231
20251

Applicants with the most clearances

Product code POM
Applicants holding the most 510(k) clearances under product code POM
ApplicantClearances
Impact Applications, Inc.6
Sway Medical, Inc.1
Vista Lifesciences, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code