Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)

The Manual Wheelchair (Models S002, S004, S005, S006, S007, S008, S009) is a mechanically operated device with four wheels, a foldable frame, seat, footrests, and hand rims that enables mobility for persons restricted to a sitting position. It can be used indoors or outdoors on dry, level surfaces and features manual brakes and push handles for assistant propulsion.

Both the proposed device and predicate share manual operation, four-wheel design, foldable frame with cross-brace, fixed backrest, swing-away/elevating footrests, and occupant-operated manual brakes. The proposed device differs in specific dimensions (seat width 380mm vs. 405-505mm), weight (12.5-14.5kg vs. 20-22.6kg), weight capacity (100kg vs. 136kg), and tire sizes, but all variants passed applicable ISO dimensional and performance standards.

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 strengths), ISO 7176-11 (test dummies), ISO 7176-13 (friction coefficient), ISO 7176-15 (labeling and documentation), ISO 16840-10 (ignition resistance), and ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation).

The proposed device is substantially equivalent because it shares the same intended use (mobility for seated patients), classification (Class I mechanical wheelchair), and core design characteristics (manual operation, foldable frame, occupant-controlled braking) as the predicate K232230. Although dimensional and weight parameters differ, both devices passed the same ISO performance and strength standards, and these differences do not create new safety or effectiveness risks per the applicant's analysis.