Electric wheelchair (JJW-7002, JJW-7003)

The JJW-7002 and JJW-7003 are battery-powered electric wheelchairs designed to provide mobility for disabled or elderly persons limited to a seated position. They are four-wheeled vehicles controlled by a joystick, operable both indoors and outdoors, with an automatic electronic braking system and Li-ion battery power.

The subject devices use brushless motors (24V, 250W) versus the predicate's brushed DC motor. They feature carbon fiber frames instead of aluminum alloy and slightly different braking distance (≤1.0 m vs ≤1.5 m). Battery capacities and travel range differ: JJW-7002 has dual 24V 7.5Ah batteries with 18.4 km range; JJW-7003 has single 24V 10Ah battery with 13.7 km range. Maximum safe inclines are 10° for JJW-7002 and 6° for JJW-7003 versus 6° for predicate.

ISO 7176 series (Parts 1–15, 21–22, 25), ISO 16840-10 (resistance to ignition), ISO 10993 (biocompatibility), IEC 60601-1-2 (electromagnetic compatibility), and FDA 1995 Guidance on 510(k) Submissions for Mechanical and Powered Wheelchairs. Enhanced-level software documentation per FDA's 2023 Guidance on Device Software Functions.

Both devices comply with the same ISO 7176 standards and perform similarly regarding static and dynamic stability, braking, distance range, dimensions, weight, speed, and obstacle-climbing ability. Non-clinical laboratory testing demonstrates the subject device meets acceptance criteria and performs within acceptable specifications identical to the predicate. Minor parameter differences (frame material, motor type, battery configuration) do not affect safety or performance per ISO 7176 testing.