Power Wheelchair (D10, D12, D15, D17, D20, D37)

The Power Wheelchair (models D10, D12, D15, D17, D20, D37) is a motor-driven, foldable, battery-operated vehicle intended to provide indoor and outdoor mobility to disabled or elderly persons limited to a seated position. It features rear-wheel drive, electromagnetic braking, joystick control, and optional Bluetooth remote control capabilities.

The device uses brushless or brush motors (250W for some models, 180W for others), rechargeable lithium-ion batteries (24V 6Ah×2 or 20Ah capacity), aluminum alloy or carbon fiber frames, and PU solid tires in various sizes (7–12.5 inches). It achieves up to 6 km/h maximum speed, up to 20 km travel range, and can climb obstacles of 20–50 mm depending on model. Differences from the predicate include Bluetooth remote control (predicate had joystick-only), frame material variation, and minor dimensional and performance parameter differences.

ISO 7176 series (Parts 1–15, 21–22, 25), IEC 62133-2:2017 (battery safety), IEC 60601-1-2:2020 (electromagnetic compatibility), ISO 10993 series (biocompatibility), ISO 14971:2019 (risk analysis), and ISO 16840-10:2021 (ignition resistance).

The subject device and predicate device (K212092) are both Class II powered wheelchairs complying with identical ISO 7176 series standards and IEC requirements for battery and EMC testing. Although the subject device adds Bluetooth remote control capability (present in reference device K223393), all safety and performance parameters—including static/dynamic stability, braking, speed, obstacle climbing, and biocompatibility—meet the same test criteria and standards. Minor differences in frame material, battery capacity, motor power, and dimensions do not affect safety or effectiveness, as all tests are conducted to the same standards with maximum-rated-weight dummies. Therefore, the subject device performs substantially equivalently to the predicate in all clinically relevant aspects.