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FDA PRODUCT CODE · CLASS II

POM — Computerized Cognitive Assessment Aid For Concussion

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

DEVICE CLASS
Class II
REGULATION
21 CFR 882.1471
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

K241737Sway Medical, Inc. · 510k2025-02-15

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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