FDA Product Code INI: Vehicle, Motorized 3-wheeled
Three-wheeled motorized vehicles provide enhanced outdoor mobility for people with physical disabilities. FDA product code INI covers motorized three-wheeled mobility vehicles cleared as medical devices.
These scooter-style devices use a battery-powered motor and tiller steering to provide independent mobility for individuals who can sit upright but cannot walk distances. They offer greater stability on uneven terrain than four-wheeled scooters due to their turning radius.
INI devices are Class II medical devices, regulated under 21 CFR 890.3800 and reviewed by the FDA Physical Medicine panel.
Leading manufacturers include Heartway Medical Products Co., Ltd. and Wu'S Tech Co., Ltd..
List of Vehicle, Motorized 3-wheeled devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Vehicle, Motorized 3-wheeled devices (product code INI). 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 →