FDA 510(k) Application Details - K241737

Device Classification Name	More FDA Info for this Device
510(K) Number	K241737
Device Name	Sway System Sports Plus
Applicant	Sway Medical, Inc. 32 S. Lewis Ave Tulsa, OK 74104 US Other 510(k) Applications for this Company
Contact	Alex Pettigrew Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2024
Decision Date	02/15/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review