Manual Wheelchair (W47)

The W47 Manual Wheelchair is a mechanical device designed to provide mobility to adults (age ≥22 years) who are limited to a sitting position. It features four wheels, a steel frame, flame-resistant seat and back upholstery, hand brake levers, and parking brakes. The device weighs approximately 24 kilograms and has a weight capacity of 136 kilograms.

The W47 has dimensions of 1340mm × 690mm × 950mm with a seat of 580mm × 450mm × 465mm. It features a non-flip back/non-height adjustable armrest, offset quick-release rear axle, 606mm rear wheels, 198mm front casters, adjustable headrest, and pull-to-lock wheel brakes. Materials include steel frame and polyurethane foam for seat/backrest/arm pads. The predicate device (Merits R106/R136) has adjustable armrests and multiple axle positions, representing minor design variations that do not affect safety or effectiveness.

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/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 7176-22 (set-up procedures), and ISO 10993-1 (biocompatibility evaluation).

The W47 is substantially equivalent to the predicate Merits R106/R136 Rehab Wheelchair (K170517) because both are mechanical manual wheelchairs with identical product codes (IOR) and indications for use, comply with the same ISO standards, and demonstrate equivalent performance in static stability, dimensions, weight, brake effectiveness, and structural strength. Minor dimensional differences (caster diameter, armrest adjustability, seat dimensions) do not affect safety or effectiveness, and both devices use equivalent materials and biocompatible substances.