Duns Number:080143399
Device Description: Nova chat 5.3 is a speech generating device with a 5 inch screen. The NC5.3 is our smalle Nova chat 5.3 is a speech generating device with a 5 inch screen. The NC5.3 is our smallest integrated communication system that offers the well-known Chat software on an Android platform. Like all "Chats," NOVA chat 5 offers a durable yet sleek portable design, with features that include a 5" display, multiple position capabilities, switch scanning, Social Chat, IVONA speech synthesizer, and many other Chat features.
Catalog Number
-
Brand Name
Nova Chat
Version/Model Number
NC5.3
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
cb0522d5-9fc7-4aa1-82f8-bdbb754b5ed7
Public Version Date
February 13, 2019
Public Version Number
3
DI Record Publish Date
September 24, 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 |