Duns Number:080143399
Device Description: Accent™ 800 is an integrated speech device and offers advanced functionality and user-frie Accent™ 800 is an integrated speech device and offers advanced functionality and user-friendly features. It is the smallest and most portable PRC device that offers a variety of vocabulary options.The Accent 800 offers a choice of vocabulary options featuring Unity® with LAMP/Words for Life™, CoreScanner™, and WordCore. Other available vocabulary options include Essence™ for literate adults and WordPower™. The Accent 800 is powered by PRC’s NuVoice™ software and offers built in support resources for clinicians and clients.
Catalog Number
-
Brand Name
Accent 800
Version/Model Number
ACN800-20
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
8cb566fd-7856-4c3f-ba9c-191ace1a4b6b
Public Version Date
March 29, 2018
Public Version Number
2
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 |