Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)

The Power Wheelchair (models D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) is a motor-driven, foldable, battery-operated transportation device for indoor and outdoor use. It is intended to provide mobility to disabled or elderly persons limited to a seated position, featuring joystick control and optional Bluetooth remote control.

The subject device uses brush motors (180–250W) or brushless motors with intelligent electromagnetic brakes, aluminum-alloy frames, and lithium-ion batteries (24V 10Ah or 6Ah×2). Key differences from the predicate include Bluetooth remote-control capability (predicate had joystick only), varied rear wheel sizes (8–12 inches vs. predicate's 8 inches), and higher maximum speed braking distance (<1m vs. 0.5m). All safety and performance validated per maximum-rated-weight dummy testing.

ISO 7176 series (Parts 1–15, 21–22, 25); ISO 16840-10:2021; IEC 60601-1-2:2020; IEC 62133-2:2017; ISO 10993-1, -5, -10, -23; ANSI C63.27:2021; AAMI TIR69:2017; FCC 47 CFR 15.247; ISO 14971:2019 (risk analysis).

The subject device performs substantially equivalent functions to predicate K212092 under the same ISO 7176 standards and demonstrates equivalent safety across static/dynamic stability, braking, battery safety, biocompatibility, and electromagnetic compatibility. Although the subject device adds Bluetooth remote control and has minor dimensional and motor-power variations, these differences do not raise new safety or effectiveness concerns because all performance is validated to maximum-rated-weight requirements and the Bluetooth functionality is functionally similar to the reference device's smartphone-app control, with cybersecurity validation confirming no new risks.