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 Corporation.
List of Wheelchair, Mechanical devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Wheelchair, Mechanical devices (product code IOR). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Physical Medicine FDA review panel. Browse all Physical Medicine devices →