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510(k) K202485

ImPACT Version 4 by Impact Applications, Inc. — Product Code POM

K202485 is an FDA 510(k) premarket notification submitted by Impact Applications, Inc. for the device "ImPACT Version 4". The FDA issued a decision of Substantially Equivalent on December 25, 2020. The device falls under product code POM (Computerized Cognitive Assessment Aid For Concussion), a Class II device regulated under 21 CFR 882.1471. Impact Applications, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 25, 2020
Date Received
August 31, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computerized Cognitive Assessment Aid For Concussion
Device Class
Class II
Regulation Number
882.1471
Review Panel
NE
Submission Type

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

Other clearances by Impact Applications, Inc.

  • K231688 — ImPACT Version 4 (September 16, 2023)
  • K181223 — ImPACT (October 20, 2018)
  • K170551 — ImPACT Quick Test (June 21, 2017)
  • K170209 — ImPACT (February 23, 2017)
  • DEN150037 — ImPACT Computerized Neurocognitive Concussion Management Aid (August 22, 2016)

Other clearances for product code POM

  • K241737 — Sway System Sports Plus (February 15, 2025)
  • K231688 — ImPACT Version 4 (September 16, 2023)
  • K201376 — ANAM Test System (March 25, 2021)
  • K181223 — ImPACT (October 20, 2018)
  • K170551 — ImPACT Quick Test (June 21, 2017)
  • K170209 — ImPACT (February 23, 2017)
  • DEN150037 — ImPACT Computerized Neurocognitive Concussion Management Aid (August 22, 2016)

FDA data resources