FDA Product Code IOR: Wheelchair, Mechanical

Manual wheelchairs remain the most widely used mobility device globally. FDA product code IOR covers mechanical wheelchairs propelled by the user or an attendant.

These devices provide seated mobility for individuals who cannot walk due to spinal cord injury, lower limb amputation, or other conditions. They range from lightweight sport chairs to heavy-duty tilt-in-space systems for complex positioning needs.

IOR devices are Class I medical devices, regulated under 21 CFR 890.3850 and reviewed by the FDA Physical Medicine panel.

Leading manufacturers include Invacare Corp., Colours 'N Motion and Freedom Designs, Inc..