Duns Number:531893653
Device Description: The AT-910 ("A10tion") is a is a virtual reality, immersive therapeuticapplication, indica The AT-910 ("A10tion") is a is a virtual reality, immersive therapeuticapplication, indicated to train and improve cognitive function of patients withdiagnosed ADHD. This application is a clinician- monitored program and should beconsidered for use as part of the therapeutic program that include clinician directedtherapyThis multidimensional training program application targetsattention, executive function and memory combined with motor activationthrough the use of games and entertainment features.
Catalog Number
VRCBT AT-910
Brand Name
VRCBT
Version/Model Number
AT-910 (A10tion)
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 05, 2021
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PTY
Product Code Name
Computerized Cognitive Assessment Aid, Exempt
Public Device Record Key
6ca83cb2-5137-409e-abed-e021a4077705
Public Version Date
September 16, 2022
Public Version Number
6
DI Record Publish Date
June 15, 2021
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. | 14 |