U.S. FDA regulated wheelchairs as medical devices:
Mechanical Wheelchair.
Powered Wheelchair.
Special Grade Wheelchair.
Stair-climbing Wheelchair.
Standup Wheelchair.
Motorized Three-wheeled Vehicle.
ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577
https://www.itbhdg.com/medical-devices-registration/