Duns Number:619142540
Device Description: The Bertec Vision Trainer System (BVT) is a device that objectively measures the performan The Bertec Vision Trainer System (BVT) is a device that objectively measures the performance of subject’s visuo-motor skills. It consists of a large touchscreen monitor, a force plate, and the BVT software. The subject interacts with the screen by touching and/or moving their center of pressure in response to a target stimulus, both dynamic and static.
Catalog Number
95P-0014
Brand Name
Bertec Vision Trainer System (BVT)
Version/Model Number
95P-0014
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IKK
Product Code Name
System, Isokinetic Testing And Evaluation
Public Device Record Key
d1197ada-f530-4a00-8657-debcd2658c87
Public Version Date
February 01, 2022
Public Version Number
1
DI Record Publish Date
January 24, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |