Duns Number:619142540
Device Description: Bertec Balance Advantage Functional system is a clinical balance assessment device that co Bertec Balance Advantage Functional system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
Catalog Number
-
Brand Name
Balance Advantage Functional System
Version/Model Number
97P-0005
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KHX
Product Code Name
Platform, Force-Measuring
Public Device Record Key
f1b6f54e-d20c-4494-a319-77ab7b9694b2
Public Version Date
January 13, 2021
Public Version Number
1
DI Record Publish Date
January 05, 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 |
|---|---|---|
| 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 |