POMClass II
Computerized Cognitive Assessment Aid For Concussion
Neurology · 21 CFR 882.1471
For use as an assessment aid in the management of concussion.
MDR events0All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances8All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- Sway Medical, Inc.Feb 15, 2025
K241737 · Sway System Sports Plus
- Impact Applications, Inc.Sep 16, 2023
K231688 · ImPACT Version 4
- Vista Lifesciences, Inc.Mar 25, 2021
K201376 · ANAM Test System
- Impact Applications, Inc.Dec 25, 2020
K202485 · ImPACT Version 4
- Impact Applications, Inc.Oct 20, 2018
K181223 · ImPACT
- Impact Applications, Inc.Jun 21, 2017
K170551 · ImPACT Quick Test
- Impact Applications, Inc.Feb 23, 2017
K170209 · ImPACT
- Impact Applications, Inc.Aug 22, 2016
DEN150037 · ImPACT Computerized Neurocognitive Concussion Management Aid