Duns Number:080143399
Device Description: Chat Fusion 8.1 is a speech generating device with an 8 inch screen. Fusion offers multipl Chat Fusion 8.1 is a speech generating device with an 8 inch screen. Fusion offers multiple access methods including Chat Point (optional headpointing), a front and rear camera, and extended battery life. Single or dual switch and advanced scanning features are incorporated into the device as well. Additionally, a wheelchair mounting plate has been included for your convenience.
Catalog Number
-
Brand Name
Chat Fusion
Version/Model Number
CF8.1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILQ
Product Code Name
System, Communication, Powered
Public Device Record Key
68b6dd86-c951-404f-924e-cad7cac49320
Public Version Date
February 13, 2019
Public Version Number
3
DI Record Publish Date
November 30, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 198 |