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510(k) K231688

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2023
Date Received
June 9, 2023
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.

  • K202485 — ImPACT Version 4 (December 25, 2020)
  • 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)
  • K201376 — ANAM Test System (March 25, 2021)
  • K202485 — ImPACT Version 4 (December 25, 2020)
  • 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)