Manual Wheelchair (W45)

The W45 Manual Wheelchair is a mechanical wheelchair designed to provide mobility for adults aged 22 years and older who are limited to a sitting position. It features an aluminum frame, nylon upholstery, four wheels, and hand brake levers with a squeeze-locking parking mechanism. The device weighs approximately 12 kg and has a maximum weight capacity of 115 kg.

The W45 has overall dimensions of 1010mm × 610mm × 920mm with a foldable aluminum frame, fixed backrest and armrests, quick-release rear axle, and front and rear wheel dimensions of 200mm and 310mm respectively. Compared to the predicate device (K181795), the W45 is lighter (12kg vs 17.2kg) and has slightly different dimensions and wheel sizes, but these differences are minor and do not affect performance or safety. Both devices feature similar mechanical control, nylon upholstery, and frame materials.

ISO 7176-1, ISO 7176-3, ISO 7176-5, ISO 7176-7, ISO 7176-8, ISO 7176-11, ISO 7176-13, ISO 7176-15, ISO 7176-22, ISO 16840-10, and ISO 10993-1 (biocompatibility). Testing addressed static stability, brake effectiveness, dimensions and mass, seating measurements, strength requirements, test dummies, friction coefficients, labeling requirements, and resistance to ignition.

The W45 is substantially equivalent to predicate device K181795 because both comply with identical ISO standards, perform similarly across all tested parameters, and demonstrate equivalent safety and effectiveness. Both are Class I mechanical wheelchairs with the same regulatory classification and product code, similar control mechanisms and materials, and both passed performance testing for static ability, dimensions, weight, strength, and other critical safety parameters.