Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)

The Electric Wheelchair (Robooter E80), models BBR-E80-01 and BBR-E80-02, is a battery-operated, rear-wheel drive powered wheelchair designed to provide indoor and outdoor mobility to persons limited to a seated position who can operate a powered wheelchair. It features a control pad on the right armrest, electromagnetic braking, Bluetooth 4.1 remote control via smartphone app, and manually foldable design with interchangeable handrails.

The subject device uses a carbon fiber frame (vs. alloy in predicate), slightly larger dimensions, different battery options (12Ah or 20Ah lithium-ion vs. 20Ah), and enhanced Bluetooth control capabilities. Both employ electromagnetic braking, rear-wheel drive, similar operating/storage temperature ranges, and identical wireless RF specifications. Minor differences exist in seat width (540mm vs. 420mm), obstacle-climbing height (10mm vs. 40mm), and turning radius (975mm vs. 900mm).

ISO 7176 series (Parts 1–15, 21, 25) for wheelchair stability, braking, energy consumption, dimensions, strength, climatic performance, obstacle-climbing, seating, electromagnetic compatibility, and battery/charger requirements. Additionally, ISO 10993 series (Parts 5, 10, 23) for biocompatibility, ISO 16840-10 for ignition resistance, and ANSI C63.27-2017 for wireless coexistence.

The subject device is substantially equivalent to the predicate (Electric Wheelchair Robooter E40, K231868) because both share identical intended use, same regulatory classification (Class II, 21 CFR 890.3860), product code (ITI), and over-the-counter designation. All dimensional and performance differences comply with ISO 7176 standards and do not adversely affect safety or effectiveness. Both use equivalent materials for user contact, employ the same braking and drive systems, and meet identical EMC and battery safety requirements.