Duns Number:080143399
Device Description: This Keyguide is made from clear polycarbonate material and precisely engineered to help g This Keyguide is made from clear polycarbonate material and precisely engineered to help guide the user’s touch to targeted icons on the screen and reduce accidental activations. A tactile Keyguide allows the Accent 1000 to be set up to accommodate a wide range of cognitive and motor skills for the visually impaired. Using the Keyguide with the 1000 requires the device frame that came with the 1000.This keyguide has rectangular/oval openings and tactile ques for the visually impaired.
Catalog Number
-
Brand Name
Accent 1000 Tactile Keyguide 84 Location (LAMP WFL VI)
Version/Model Number
18711-84
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
2514843d-1863-4b49-a05f-ff35bf43d78b
Public Version Date
December 31, 2018
Public Version Number
1
DI Record Publish Date
November 29, 2018
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 |