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 Wu'S Tech Co., Ltd., Heartway Medical Products Co., Ltd. and Pride Health Care, Inc..