K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR))

The K5 wheelchair is a manually operated mechanical device with four wheels intended to provide mobility to persons restricted to a sitting position. It features a foldable frame, adjustable footrests, hand rims for user propulsion, brakes, and push handles for assistant-aided movement. The device is available in six models with different seat widths (16", 18", 20") and footrest options (swing-away or elevated).

The K5 has similar core design characteristics to the predicate (manual operation, four wheels, foldable cross-brace frame, detachable armrests, adjustable footrests, occupant-operated brakes). Key differences include smaller overall dimensions (1850mm L vs 1340mm), lower weight (17.3kg vs 25.5kg), reduced weight capacity (250 lbs vs 350 lbs), narrower seat (405mm vs 410-510mm), and slightly different tire sizes. These dimensional and weight differences do not introduce new safety or effectiveness risks.

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

The K5 is substantially equivalent to predicate K232198 because both are Class I mechanical wheelchairs with identical indications for use, same core design features (manual operation, foldable frame, mechanical brakes), and compliance with the same performance and biocompatibility standards. Although the K5 has different dimensions and weight specifications, it passed the relevant ISO dimensional and structural tests, demonstrating these differences do not raise new safety or effectiveness concerns.