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, Zhenjiang Assure Medical Equipment Co., Ltd. and Jiangsu Jumao X-Care Medical Equipment Co., Ltd..
FDA 510(k) Cleared Wheelchair, Mechanical Devices (Product Code IOR)
About Product Code IOR - Regulatory Context
510(k) Submission Activity
454 total 510(k) submissions under product code IOR since 1978, with 454 receiving FDA clearance (average review time: 78 days).
Submission volume has remained relatively stable over the observed period, with 14 submissions in the last 24 months.
FDA Review Time
Recent submissions under IOR have taken an average of 121 days to reach a decision - up from 76 days historically. Manufacturers should account for longer review timelines in current project planning.
IOR devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →