Alum Creek Wheelchair Co., Inc.
Country not established
- Devices
- 1
What Alum Creek Wheelchair Co., Inc. makes
Alum Creek Wheelchair Co., Inc. manufactures manual wheelchairs, including the Gazelle Wheelchair, designed for mobility assistance in indoor and outdoor environments. These devices are intended for individuals requiring seated transport due to mobility limitations, with a focus on durability and user comfort.
The company’s products fall under Class I medical devices in the U.S., regulated under the FDA’s 510(k) clearance pathway. The Gazelle Wheelchair is listed in the FDA’s 510(k) database, adhering to U.S. regulatory requirements for manual wheelchairs. The manufacturer operates from the United States.
Catalogue
Gazelle Wheelchair Ref K020536
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Alum Creek Wheelchair Co., Inc. have in the registry?
The registry currently lists 1 device for Alum Creek Wheelchair Co., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alum Creek Wheelchair Co., Inc.'s devices?
Among its 1 most recently registered device, Alum Creek Wheelchair Co., Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Alum Creek Wheelchair Co., Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Alum Creek Wheelchair Co., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Alum Creek Wheelchair Co., Inc. in the registry?
The most recently registered devices listed for Alum Creek Wheelchair Co., Inc. include GAZELLE WHEELCHAIR.