Power wheelchair

The EL-001 is a motor-driven, foldable electric wheelchair designed for indoor and outdoor use. It provides mobility to disabled or elderly persons who are limited to a seated position and is controlled via a joystick.

The proposed device uses a steel and aluminum frame with 6 wheels (two front driven wheels, two rear driving wheels, two anti-tip wheels), an automatic electromagnetic brake system, dual brushless DC motors (350W each at 24VDC), lead-acid batteries (12VDC 50Ah×2), and an electronic dynamic controller. It differs from the predicate in frame material (steel+aluminum vs. carbon steel), wheel sizes (9″ and 13″ vs. 6″ and 10″), and battery capacity, but maintains equivalent safety and performance characteristics.

ISO 7176 series (Parts 1–15, 21–22, 25) for wheelchair performance, stability, braking, speed, strength, and batteries; ISO 10993 series (Parts 1, 5, 10, 23) for biocompatibility; ISO 16840-10 for flame-retardant testing; ISO 14971 for risk analysis; IEC 60601-1-2 and IEC TR 60601-4-2 for electromagnetic compatibility.

The proposed device and predicate (HP330, K244003) share identical indications for use, the same ISO compliance framework, equivalent design principles for controllers and brake systems, and materially equivalent safety testing outcomes. Minor differences in frame material, wheel sizes, battery capacity, and obstacle-climbing height do not raise new safety or effectiveness concerns because both devices meet the same ISO 7176 and ISO 10993 standards.