FDA 510(k) Application Details - K243366

Device Classification Name	Equipment, Traction, Powered   More FDA Info for this Device
510(K) Number	K243366
Device Name	Equipment, Traction, Powered
Applicant	Excite Medical of Tampa Bay, LLC 4710 Eisenhower Blvd N Suite A-12 Tampa, FL 33549 US Other 510(k) Applications for this Company
Contact	Saleem Musallam Other 510(k) Applications for this Contact
Regulation Number	890.5900   More FDA Info for this Regulation Number
Classification Product Code	ITH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2024
Decision Date	06/18/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review