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 Anhui Jbh Medical Apparatus Co., Ltd., Invacare Corporation and Kunshan Hi-Fortune Health Products Co., Ltd..
FDA 510(k) Cleared Wheelchair, Powered Devices (Product Code ITI)
About Product Code ITI - Regulatory Context
510(k) Submission Activity
575 total 510(k) submissions under product code ITI since 1978, with 575 receiving FDA clearance (average review time: 121 days).
Submission volume has increased in recent years - 78 submissions in the last 24 months compared to 19 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for ITI submissions have been consistent, averaging 127 days recently vs 120 days historically.
ITI devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →