Duns Number:084042331
Device Description: The ManaEZ Rom Elite adjustable knee brace allows the user to adjust the length of the bra The ManaEZ Rom Elite adjustable knee brace allows the user to adjust the length of the brace for custom fitting. This product is ideal for knee ligament damage, knee surgeries, and instability of the knee. The ManaEZ Rom Elite is designed for post-operative fixation, allowing the doctor to lock the patient into extension and control range of motion as prescribed. ManaEZ ROM Elite is a quick fitting, universal, telescoping, and drop lock post op knee brace. The brace has a unique malleable bar system to conform to all shapes and sizes.-Telescoping and malleable hinge bars extendable from 16.5" - 27" (42cm - 68.5cm)-Hinge range of motion adjustment: Flexion (0° - 120°) and extension (0° - 90°)-Quick lock key offers ability to control and lock out the hinge motion to 0°, 15°, and 30° directly-Lightweight, latex free breathable material-Easy application, universal size with hook and buckle closure, design fits either leg
Catalog Number
EZRS1833
Brand Name
ManaMed
Version/Model Number
ManaEZ ROM Elite Short
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
ITQ
Product Code Name
Joint, Knee, External Brace
Public Device Record Key
5dc0f5ea-0dfe-4e48-8af6-3f1082b5b96f
Public Version Date
August 30, 2022
Public Version Number
2
DI Record Publish Date
June 21, 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 |