Foundation For Fluency, Inc.
Country not established
- Devices
- 1
What Foundation For Fluency, Inc. makes
Foundation For Fluency, Inc. manufactures the Edinburgh Masker, a device designed to assist with speech and hearing therapy by masking background noise for improved auditory clarity.
The Edinburgh Masker is classified as a Class I medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Edinburgh Masker Ref K800445
510(k) 510(k)
Frequently asked questions
How many devices does Foundation For Fluency, Inc. have in the registry?
The registry currently lists 1 device for Foundation For Fluency, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Foundation For Fluency, Inc.'s devices?
Among its 1 most recently registered device, Foundation For Fluency, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Foundation For Fluency, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Foundation For Fluency, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Foundation For Fluency, Inc. in the registry?
The most recently registered devices listed for Foundation For Fluency, Inc. include EDINBURGH MASKER.