510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN150037Unknown

ImPACT Computerized Neurocognitive Concussion Management Aid

Impact Applications, Inc., Pittsburgh PA / Direct, Unknown
FDA source (opens on fda.gov)

DEN150037 is the FDA 510(k) clearance record for ImPACT Computerized Neurocognitive Concussion Management Aid, a class II device, cleared for Impact Applications, Inc. on under FDA product code POM (Computerized Cognitive Assessment Aid For Concussion). FDA's definition for product code POM reads: "For use as an assessment aid in the management of concussion". FDA records list 6 510(k) clearances for Impact Applications, Inc., from to . As of , FDA records show no recalls naming DEN150037.

Clearance record

Decision date
Received
(377 days to decision)
Product code
POM Computerized Cognitive Assessment Aid For Concussion
Regulation
21 CFR 882.1471
Device class
Class II
Review panel
Neurology
Applicant
Impact Applications, Inc. 2000 Technology Dr., Suite 150, Pittsburgh PA
Third party review
No

Clearances, product code POM

Trailing 12 months

FDA records hold no clearances under product code POM in the trailing twelve months.

FDA records show no clearances under product code POM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code POM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260