Oni, Inc.
Country not established
- Devices
- 1
What Oni, Inc. makes
Oni, Inc. manufactures the ORTHONE, a device designed for orthopedic applications, likely intended for spinal or limb alignment support.
The ORTHONE is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. Oni, Inc. is based in the United States.
Catalogue
Orthone Ref K001773
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Oni, Inc. have in the registry?
The registry currently lists 1 device for Oni, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oni, Inc.'s devices?
Among its 1 most recently registered device, Oni, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Oni, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Oni, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Oni, Inc. in the registry?
The most recently registered devices listed for Oni, Inc. include ORTHONE.