Breakthrough, Inc.
Country not established
- Devices
- 1
What Breakthrough, Inc. makes
Breakthrough, Inc. manufactures the Iowa Oral Performance Instrument, a device designed for assessing oral motor function and swallowing ability in clinical settings.
The company’s portfolio is regulated under FDA Class I devices and requires 510(k) clearance. The manufacturer is based in the United States.
Catalogue
Iowa Oral Performance Isntrument Ref K920091
510(k) 510(k)
Frequently asked questions
How many devices does Breakthrough, Inc. have in the registry?
The registry currently lists 1 device for Breakthrough, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Breakthrough, Inc.'s devices?
Among its 1 most recently registered device, Breakthrough, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Breakthrough, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Breakthrough, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Breakthrough, Inc. in the registry?
The most recently registered devices listed for Breakthrough, Inc. include IOWA ORAL PERFORMANCE ISNTRUMENT.