KLAXON (TWIST); KLAXON (TWIST R)

The Klaxon TWIST and TWIST R are add-on motorized drive accessories for manual wheelchairs designed to provide auxiliary power and reduce pushing effort for active wheelchair users. They can be mounted front or rear and come in multiple configurations with or without handlebars, converting manual wheelchairs into electrically driven devices while maintaining user control and mobility.

The subject device increases maximum front-mounted speed with handlebar from 10 km/h to 15 km/h and raises maximum user weight capacity from 120 kg to 140 kg when rear-mounted. All other specifications remain identical to the predicate, including motor type (brushless, 24V, 150W), battery (rechargeable Li-ion), range (21 km), brake system, and dimensions.

ISO 7176-1:2014 (static stability), ISO 7176-2:2017 (dynamic stability of electrically powered wheelchairs), ISO 7176-3:2012 (brake effectiveness), and ISO 7176-8:2014 (static, impact, and fatigue strength testing) were applied to validate the changes.

The subject device is substantially equivalent to predicate K240267 because the performance changes (increased speed capability and user weight capacity) are isolated modifications to the same basic design that have been validated through recognized consensus standards demonstrating acceptable safety and performance. The changes do not affect intended use or indications, and identical testing methodologies confirm the modified device maintains substantially equivalent safety and performance characteristics to the predicate.