Duns Number:084042331
Device Description: The Royal Boot is a tall pneumatic walker boot built with a unique rocker bottom to simula The Royal Boot is a tall pneumatic walker boot built with a unique rocker bottom to simulate natural gait.Athletic bottom designLarge air bladder creates a larger surface for contact pressure to control swelling and ensure snug fit
Catalog Number
RB001XS
Brand Name
ManaMed
Version/Model Number
Royal Boot Air XS
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
f15500cc-b74e-4108-94bc-752d863917cf
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 |