Duns Number:080028759
Device Description: KNEEHAB PLUS GARMENT EXTENDER KIT
Catalog Number
-
Brand Name
Neurotech Kneehab
Version/Model Number
0411-5038
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
-
Product Code
IPF
Product Code Name
Stimulator, Muscle, Powered
Public Device Record Key
56851535-241d-4e5f-9bd6-bd51d4af92d5
Public Version Date
February 19, 2021
Public Version Number
6
DI Record Publish Date
December 05, 2016
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. | 15 |
3 | A medical device with high risk that requires premarket approval | 11 |