Duns Number:437634351
Device Description: huno s is a robotic medical device for functional sensorimotor rehabilitation and evaluati huno s is a robotic medical device for functional sensorimotor rehabilitation and evaluation of the lower limbs and trunk
Catalog Number
APC0000404
Brand Name
huno s
Version/Model Number
huno s
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
IKK
Product Code Name
System, Isokinetic Testing And Evaluation
Public Device Record Key
c64e3dfa-5f91-498b-a5f8-376e69a94530
Public Version Date
September 10, 2019
Public Version Number
1
DI Record Publish Date
September 02, 2019
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. | 3 |