Duns Number:524664525
Device Description: Sens is an inertial sensor to measure the range of motion and to compare the symmetry betw Sens is an inertial sensor to measure the range of motion and to compare the symmetry between the injured limb’s amplitude andthe healthy limb.
Catalog Number
-
Brand Name
KINVENT
Version/Model Number
Sens 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
KQX
Product Code Name
Goniometer, Ac-Powered
Public Device Record Key
51ce64df-960f-4115-8295-f635b36a997d
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 |