Home / 510(k) Clearances / K241737

510(k) K241737

Sway System Sports Plus by Sway Medical, Inc. — Product Code POM

K241737 is an FDA 510(k) premarket notification submitted by Sway Medical, Inc. for the device "Sway System Sports Plus". The FDA issued a decision of Substantially Equivalent on February 15, 2025. The device falls under product code POM (Computerized Cognitive Assessment Aid For Concussion), a Class II device regulated under 21 CFR 882.1471.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2025
Date Received
June 17, 2024
Clearance Type
Traditional
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 for product code POM

  • 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)
  • K170209 — ImPACT (February 23, 2017)
  • DEN150037 — ImPACT Computerized Neurocognitive Concussion Management Aid (August 22, 2016)

FDA data resources