FDA 510(k) Application Details - K250729

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K250729
Device Name	Wheelchair, Powered
Applicant	Vive Health LLC 8599 Fontana Del Sol Way Naples, FL 34109 US Other 510(k) Applications for this Company
Contact	Guy Savioli Other 510(k) Applications for this Contact
Regulation Number	890.3860   More FDA Info for this Regulation Number
Classification Product Code	ITI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/2025
Decision Date	07/02/2025
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