FDA Product Code ITI: Wheelchair, Powered
FDA product code ITI covers powered wheelchairs — battery-operated mobility devices for individuals who cannot propel a manual wheelchair.
These devices use an electric motor controlled by a joystick, sip-and-puff switch, or other interface to provide independent mobility for people with spinal cord injury, muscular dystrophy, ALS, and other conditions affecting upper and lower limb function.
ITI devices are Class II medical devices, regulated under 21 CFR 890.3860 and reviewed by the FDA Physical Medicine panel.
Leading manufacturers include Invacare Corporation, Heartway Medical Products Co., Ltd. and Wu'S Tech Co., Ltd..
List of Wheelchair, Powered devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Wheelchair, Powered devices (product code ITI). 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 →