Duns Number:632151952
Device Description: The Qualisys Clinical System is a camera and computer system used to quantify and graphica The Qualisys Clinical System is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. It is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics.
Catalog Number
-
Brand Name
Qualisys Clinical System
Version/Model Number
1.5.0.408
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
K171547
Product Code
LXJ
Product Code Name
Interactive Rehabilitation Exercise Devices
Public Device Record Key
bacb1fb7-9f07-46ae-aa1f-d882e9b3ce0f
Public Version Date
September 10, 2020
Public Version Number
1
DI Record Publish Date
September 02, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |