Duns Number:084042331
Device Description: This a low profile, quick-fitting figure 8 ankle brace to provide optimal ankle stabilizat This a low profile, quick-fitting figure 8 ankle brace to provide optimal ankle stabilization.Figure 8 stabilizing straps replicate athletic ankle tapingLow profile brace fits into all types of footwearUniversally sized for left or right ankleDesigned by athletes for athletes
Catalog Number
EZANKLE02XXL
Brand Name
ManaMed
Version/Model Number
ManaEZ Ankle 02 XX-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"
-
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
ITW
Product Code Name
Joint, Ankle, External Brace
Public Device Record Key
0e10fb58-db22-4150-8e99-c9a8ab6dee0a
Public Version Date
June 28, 2022
Public Version Number
1
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 |