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:
- 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