Manual Wheelchair (7101L, 7102LHD)

The Manual Wheelchair (models 7101L, 7102LHD) is a composite-based, mechanically operated wheelchair designed for adults restricted to a sitting position to provide mobility. It consists of a frame, armrest, push handle, foot bracket, foot pedal, brake, wheels, seat and back upholstery, and anti-tippers, and is intended for both indoor and outdoor use.

The subject device is rigid (non-folding) with weight capacities of 250 lbs (7101L) or 350 lbs (7102LHD), adjustable seat dimensions, one-hand operated brakes with push-to-lock style, optional push handle and anti-tip features, and self/user-propelled manual mechanical control. Minor differences in weight, seat dimensions, and weight capacity compared to the predicate are similar in function and design.

ISO 7176-1 (static stability), ISO 7176-3 (brake effectiveness), ISO 7176-7 (seating and wheel dimensions), ISO 7176-8 (static, impact and fatigue strengths), ISO 7176-11 (test dummies), ISO 7176-13 (friction coefficient), ISO 7176-15 (labeling and documentation), and ISO 7176-22 (set-up procedures).

The Manual Wheelchair has the same intended use, mode of action, and operational characteristics as the Bowhead ERA Wheelchairs (K243111 predicate). All minor differences in weight, weight capacity, and seat dimensions do not raise new safety or efficacy concerns, and performance testing to ISO 7176 standards confirms the device is safe and effective for its intended use.