Duns Number:524664525
Device Description: Link is a traction dynamometer for the measurement of isometric strength and biofeedback t Link is a traction dynamometer for the measurement of isometric strength and biofeedback training. Link enables independent measurements. It can be fixed on a physiotherapists table, on the espalier or on pulley machines.
Catalog Number
-
Brand Name
KINVENT
Version/Model Number
Link V2R01
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LBB
Product Code Name
Dynamometer, Ac-Powered
Public Device Record Key
27341b41-d05c-40c9-9886-aed72ca6cf66
Public Version Date
November 30, 2021
Public Version Number
2
DI Record Publish Date
August 01, 2020
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |