DEVICE: M-Brace Air (05391512282097)
Device Identifier (DI) Information
M-Brace Air
46 RM
In Commercial Distribution
46
INDACO SRL
46 RM
In Commercial Distribution
46
INDACO SRL
The OA (Osteoarthritis) Knee Brace with Range of Motion (#46) brings your comfort to a new level with its elegant and light design. Available for the right or left knee, this brace alleviates knee pain by reducing the weight on your medial or lateral compartment by using the three-point pressure system. It is composed of two aluminum reinforced semi-rigid straps that surround the distal region (above the knee) and the proximal region (below the knee). These straps are to be custom molded to allow for an optimal torsion support. Additionally, these straps are bound together by a patented articulated aluminum support that is easily adjustable for flexion and extension and accessible within a zipped pocket.
The patient can adjust the amount of lateral pressure applied by choosing between two different buttress (cushion) thicknesses. The high surface of the brace’s sleeve allows for comfortable support around the affected joint. The patellar support on this brace is easy and simple to use and allows for a straightforward fitting of the product. Should you need to mold the brace to certain specifications or simply to wash the sleeve, the articulated support could be easily removed by unzipping the brace (see instructions). INDICATIONS: Use this knee brace for the following indications:
• Mild to moderate medial compartment OA without instability.
• Meniscus procedures.
• Chondral defect procedures.
• Moderate lateral compartment OA without instability; it is possible to reduce the load on the lateral compartment by using a “right” brace on a left leg or a “left” brace on a right leg.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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41065 | Knee support orthosis |
A stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device.
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FDA Product Code
[?]Product Code | Product Code Name |
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ITQ | Joint, Knee, External Brace |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c9f36c00-9e2f-4383-8106-4692957982fd
February 20, 2024
1
February 12, 2024
February 20, 2024
1
February 12, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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05391512286750 | 6 | 05391512282097 | In Commercial Distribution | Box Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-866-374-4050
contact@m-brace.com
contact@m-brace.com