Whirlwind Wheelchair International
Country not established
- Devices
- 1
What Whirlwind Wheelchair International makes
Whirlwind Wheelchair International manufactures the RoughRider, a manual wheelchair designed for off-road and rugged terrain use. The device is engineered to provide mobility in uneven, outdoor environments, including trails, parks, and unpaved paths, with features tailored for durability and stability in such conditions.
The RoughRider is classified as a Class I medical device under FDA regulations and has undergone 510(k) clearance. The company operates from the United States, where its products are listed in the FDA’s 510(k) registry.
Catalogue
Roughrider Ref K103212
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Whirlwind Wheelchair International have in the registry?
The registry currently lists 1 device for Whirlwind Wheelchair International. Devices recorded under merged duplicate company entries are counted once.
Which registries list Whirlwind Wheelchair International's devices?
Among its 1 most recently registered device, Whirlwind Wheelchair International has devices listed in FDA 510(k) (1 device).
What risk classes do Whirlwind Wheelchair International's devices fall under?
Among its 1 most recently registered device, the classes recorded for Whirlwind Wheelchair International's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Whirlwind Wheelchair International in the registry?
The most recently registered devices listed for Whirlwind Wheelchair International include ROUGHRIDER.