510(k) Report

Devices descending from DEN150037

7 later devices reach ImPACT Computerized Neurocognitive Concussion Management Aid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201376ANAM Test SystemVista Lifesciences, Inc.20210—
+1K170551ImPACT Quick TestImpact Applications, Inc.20171—
+1K170209ImPACTImpact Applications, Inc.20173—
+2K241737Sway System Sports PlusSway Medical, Inc.20250—
+2K181223ImPACTImpact Applications, Inc.20182—
+3K202485ImPACT Version 4Impact Applications, Inc.20201—
+4K231688ImPACT Version 4Impact Applications, Inc.20230—