Electric Wheelchair (Model P2)

The Electric Wheelchair Model P2 is a motor-driven, battery-operated, foldable powered wheelchair intended for indoor and outdoor use. It provides mobility to disabled or elderly persons limited to a seated position, featuring a brushless motor, electromagnetic brake system, rechargeable lithium-ion battery, and joystick control.

The subject device uses a brushless DC motor (24VDC, 250W, 2 units), automatic electromagnetic braking, 24 VDC 10Ah lithium-ion battery, and off-board charger. Minor differences from the predicate include slightly larger dimensions (37.80" vs 37"), higher total mass (57.3 lbs vs 35.3 lbs), different material for back cushion and seat cushion (PET vs polyester/fabric blends), and armrest material (ABS vs polyurethane). Performance parameters are comparable: max speed 6 km/h, max weight 300 lbs, maximum safe incline 10° vs 9°, and braking distance 0.9 m vs ≤1.5 m.

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

Both devices are Class II powered wheelchairs under 21 CFR 890.3860, comply with identical ISO standards, share the same intended use, design (rear-wheel drive with joystick control), and comparable safety/performance profiles. Minor dimensional, weight, and material differences do not raise new safety or effectiveness concerns because the device meets all applicable performance standards, demonstrates equivalent braking distance, stability, and obstacle-climbing capability, and uses biocompatible materials per ISO 10993-1. The predicate device has legally marketed substantial equivalence, and the subject device's nonclinical testing shows equivalent performance across all critical parameters.