Tone World International
Country not established
- Devices
- 1
What Tone World International makes
Tone World International manufactures mechanical wheelchairs designed for mobility assistance. These devices are intended for users requiring manual propulsion, offering adjustable seating and frame configurations to accommodate varying physical needs.
The company’s products fall under FDA Class I medical devices and are listed via the 510(k) pathway. These devices are regulated under U.S. jurisdiction, adhering to FDA compliance requirements for mechanical mobility aids.
Catalogue
Wheelchair, Mechanical Ref K941976
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Tone World International have in the registry?
The registry currently lists 1 device for Tone World International. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tone World International's devices?
Among its 1 most recently registered device, Tone World International has devices listed in FDA 510(k) (1 device).
What risk classes do Tone World International's devices fall under?
Among its 1 most recently registered device, the classes recorded for Tone World International's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Tone World International in the registry?
The most recently registered devices listed for Tone World International include WHEELCHAIR, MECHANICAL.