EmpowerRide NAVIGATOR

The EmpowerRide NAVIGATOR is a manual pediatric wheelchair designed to provide mobility to children with disabilities who are partially or permanently non-ambulatory and limited to a sitting position. It features a lightweight aluminum frame with a removable modular seating system and is intended for indoor and outdoor use on flat, firm terrain.

The device has a rigid, shock-absorbing foldable aluminum base with adjustable push handles, removable modular adaptive seating, fixed-angle footplate, and foot-actuated wheel locks. Key differences from predicates include a larger seat width (22 inches vs. 12-16 inches), no tilt-in-space mechanism, and a lighter overall weight (20 lbs vs. 29-40 lbs), but these do not affect fundamental safety or effectiveness.

ISO 7176-1:2014 (Static Stability), ISO 7176-3:2012 (Brake Effectiveness), ISO 7176-5:2008 (Dimensions and Maneuvering Space), ISO 7176-7:1998 (Seating and Wheel Measurements), ISO 7176-8:2014 (Static, Impact, and Fatigue Strength), ISO 7176-13:1989 (Coefficient of Friction), and RESNA WC1:2019 (comprehensive safety testing including labeling and upholstery flammability).

The NAVIGATOR is substantially equivalent to predicate devices (Convaid Trekker K140416, Convaid Flyer K171017, and R82 Kudu K151492) because it shares the same intended use, materials, and regulatory classification as a manual pediatric wheelchair. Although design features differ (e.g., no tilt-in-space, fixed seating), testing confirms equivalent stability, structural performance, and safety under applicable ISO and RESNA standards, with no new hazards introduced.