Powered wheelchairs and mobility scooters are regulated as Class II medical devices by FDA. Importers must ensure the device has 510(k) clearance or qualifies for an exemption, and the product must comply with applicable performance standards. FDA may detain shipments at the port of entry if documentation is incomplete.

Three- and four-wheeled mobility scooters designed for disabled persons are generally classified under 871390 (motorized invalid carriages) provided they are purpose-built for personal mobility assistance. A scooter marketed for general recreational use rather than disability accommodation may fall under a different heading, so the intended use and design specifications are key classification factors.