Power Wheelchair (YH-E6011,YH-E6013A)

The Power Wheelchair (YH-E6011, YH-E6013A) is a battery-powered, four-wheeled vehicle controlled by a joystick and designed to provide indoor and outdoor mobility for disabled or elderly persons limited to a seated position. It includes a Li-ion battery with charger, push handle, seat, back support, control panel, arm supports, anti-tip wheels, and front/rear wheels.

Minor design differences from the predicate include maximum safe operational incline degree, main frame material, armrest design, seat cushion type, rear wheel size/type, maximum speed forward, maximum loading weight, maximum travel distance on fully charged battery, turning radius, and maximum obstacle climbing height. All these parameters were tested and showed no deleterious effect on safety and effectiveness.

ISO 7176 series standards (parts 1–15, 19, 21, 25) covering static and dynamic stability, brake effectiveness, energy consumption, dimensions, maximum speed, fatigue strength, climatic testing, obstacle climbing, electromagnetic compatibility, and battery requirements. Also ISO 16840-10:2021 for resistance to ignition of seating.

The subject device has the same indications for use as the predicate (K240638) and substantially similar design and technological characteristics. Although minor parameter differences exist in frame material, wheel specifications, and performance metrics, all differences were tested per ISO 7176 standards, and test results demonstrated the subject device is as safe and effective as the predicate with no deleterious effects on intended use.