WHILL Model R

The WHILL Model R is a motor-driven electric scooter available in 3-wheel and 4-wheel variants, designed to provide indoor and outdoor mobility for disabled or elderly persons limited to a seated position. It features a removable lithium-ion battery, adjustable seating and armrests, Bluetooth-based wireless controls, and can be disassembled without tools for transport.

Key differences from the predicate (Innuovo W3331F) include: lithium-ion battery instead of lead-acid batteries; aluminum frame instead of steel; higher maximum speed (5 mph vs 3.73 mph); longer driving range (10.7-17.2 km vs 15 km); improved braking distance; and Bluetooth wireless remote control capabilities. The 4-wheel variant offers improved stability over the 3-wheel design through more even weight distribution.

Device tested to ISO 7176 series standards (static stability, dynamic stability, brakes, energy consumption, dimensions, maximum speed, seating, strength, climatic conditions, obstacle-climbing, test dummies, friction, power/control systems); ISO 10993 biocompatibility standards; IEC 62133-2 for lithium-ion battery safety; IEC 60335-2-29 and EN 60601-1-2 for charger safety; FCC 47 CFR 15.249 for wireless; ANSI C63.27-2017 for wireless coexistence; and IEC 62366-1 for usability.

Despite differences in battery chemistry (lithium-ion vs lead-acid) and charger specifications, the subject device demonstrates substantially equivalent safety and effectiveness because: (1) both pass identical ISO 7176 performance and stability testing; (2) the lithium-ion battery meets rigorous IEC 62133-2 safety standards equivalent to lead-acid testing; (3) the charger meets comparable rigorous electrical safety standards (EN 60601-1-2, IEC 60335-2-29); (4) the device shares the same indications for use, operating principles, and design approach; and (5) wireless features are identical to the reference device (WHILL Model F) which is already cleared, with the subject device actually excluding the remote-driving feature to reduce use-related and security risks.