Manual Wheelchair (W50)

The Manual Wheelchair (W50) is a mechanical wheelchair designed to provide mobility to persons limited to a sitting position. It features four wheels, a steel frame with black paint, and flame-resistant textilene upholstery, with dimensions of 1130mm × 840mm × 950mm and a weight capacity of 227 kilograms. The device is intended for adults only and includes non-flip-back armrests and a quick-release rear axle.

The proposed device and predicate device comply with the same ISO standards and perform in a similar manner. Both are mechanical wheelchairs with comparable design features including static stability, brake effectiveness, dimensions, mass, seating and wheel dimensions, structural strength (static, impact, and fatigue), and resistance to ignition. The device meets specifications for occupant mass group III with specified dimensional and weight parameters.

ISO 7176-1 (static stability), ISO 7176-3 (brake effectiveness), ISO 7176-5 (dimensions and mass), ISO 7176-7 (seating and wheel dimensions), ISO 7176-8 (static, impact, and fatigue strength), ISO 7176-11 (test dummies), ISO 7176-13 (friction coefficients), ISO 7176-15 (labeling and documentation), ISO 16840-10 (resistance to ignition), ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23 (biocompatibility testing).

The proposed device is substantially equivalent to the predicate device (K181795 Manual Wheelchair) because both comply with identical ISO standards, perform similarly, and demonstrate equivalent performance in static ability, dimensions, weight, structural strength, and resistance to ignition. Non-clinical laboratory testing confirms the device's safety and biocompatibility, and performance testing demonstrates it meets all design specifications and should perform as intended under specified use conditions.