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Concussion Management Defined

  • Baseline Testing
  • Concussion Care at School
  • Clinical Concussion Care
  • Concussion Education
  • Concussion Care Tools

Supplemental Resources

 

ImPACT Applications’ concussion care tools are Class II medical devices. They’ve been administered over 20 million times to over 13 million test takers since 2002 with no adverse outcomes reported on FDA’s MAUDE database.

ImPACT and ImPACT Pediatric are mandated in many state and local school programs as well in professional organizations around the world.

Study the evidence below for additional information:

Regulatory Notifications

  • FDA clearance letter for ImPACT Version 4
  • FDA Safety Communication - April 2019
  • FDA clearance letter for ImPACT home testing
  • FDA clearance letter for both ImPACT and ImPACT Pediatric
  • FDA clearance letter - HTML5 ImPACT
  • FDA clearance letter for ImPACT Quick Test
  • FDA Press Release - ImPACT DeNovo
  • Federal Register regulation for computerized cognitive assessment aid for concussion
  • Australian Register of Therapeutic Goods Certificate
  • ISO13485/MDSAP Certificate of Registration

Security

  • ImPACT Applications Security Overview
  • Manufacturer Disclosure Statement for Medical Device Security – MDS

Legal Documents

  • 2018 Martin Case
  • 2018 Bui Case
  • School Liability
  • 2017 MA Case

Published Research

  • Published Literature Citations

Consensus Statements

  • Computerized Neuropsychological Assessment Devices - Joint Position Paper of AAN AACN
  • AMA AIS Concussion in Sport Position Statement 2016
  • Concussion Consensus Statement Berlin
  • International Concussion Consensus 2015
  • International Consensus Statement on Concussion in Sport
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ImPACT Applications, Inc., a Riverside Insights® company, is the maker of ImPACT, ImPACT Pediatric, and ImPACT Quick Test, all FDA cleared medical devices that assist in the assessment and management of concussion. See our milestones here and access our press releases here.

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