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 Corp., Zhejiang Innuovo Rehabilitation Devices Co.,Ltd and Kunshan Hi-Fortune Health Products Co., Ltd..