Duns Number:084042331
Device Description: This universal-fit range-of-motion elbow brace is a great alternative to casting or repeti This universal-fit range-of-motion elbow brace is a great alternative to casting or repetitive splinting. Designed to treat any injury in which a limited range of elbow motion is desired.Features:Adjustable straps to fit universally.Lightweight design for comfort and ease of use.ROM hinge features flexion settings from 0-120 degrees and extension settings from 0-90 degrees.
Catalog Number
CE001R
Brand Name
ManaMed
Version/Model Number
Cabo Elbow Right
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
IQQ
Product Code Name
Joint, Shoulder, External Limb Component
Public Device Record Key
bcdc1fe7-fa91-4024-a9e4-5e743b9bf70a
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 |