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510(k) K170209

ImPACT by Impact Applications, Inc. — Product Code POM

K170209 is an FDA 510(k) premarket notification submitted by Impact Applications, Inc. for the device "ImPACT". The FDA issued a decision of Substantially Equivalent on February 23, 2017. The device falls under product code POM (Computerized Cognitive Assessment Aid For Concussion), a Class II device regulated under 21 CFR 882.1471. Impact Applications, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2017
Date Received
January 24, 2017
Clearance Type
Special
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.

  • K231688 — ImPACT Version 4 (September 16, 2023)
  • K202485 — ImPACT Version 4 (December 25, 2020)
  • K181223 — ImPACT (October 20, 2018)
  • K170551 — ImPACT Quick Test (June 21, 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)
  • K231688 — ImPACT Version 4 (September 16, 2023)
  • 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)
  • DEN150037 — ImPACT Computerized Neurocognitive Concussion Management Aid (August 22, 2016)

FDA data resources