Duns Number:084042331
Device Description: The ManaEZ Hinged Knee is a convenient wrap on hinged sleeve. The open popliteal feature a The ManaEZ Hinged Knee is a convenient wrap on hinged sleeve. The open popliteal feature allows for a comfortable fit.Wrap feature for easy on and off applicationHigh quality neopreneOpen popliteal
Catalog Number
EZHK1820XL
Brand Name
ManaMed
Version/Model Number
ManaEZ Hinged Knee Brace X-Large
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ITQ
Product Code Name
Joint, Knee, External Brace
Public Device Record Key
49af77fe-5b70-4b79-b64b-a17a304da026
Public Version Date
August 30, 2022
Public Version Number
2
DI Record Publish Date
June 20, 2022
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 | 128 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |