DEVICE: M-Brace Air (05391512282813)
Device Identifier (DI) Information
M-Brace Air
505 L/XL
In Commercial Distribution
505
INDACO SRL
505 L/XL
In Commercial Distribution
505
INDACO SRL
This Lumbar Back Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. Made with semi-rigid fabric, it enjoys a structure made with self modeling and flexible stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively im- mobilizing the lumbar-sacral region.
Two rigid abdominal panels are included. these panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. Practical and easy to wear, this brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of tension settings.
INDICATIONS
•Lumbago, sciatica and ischialgia.
•Lumbar-Sacral pain of other origin and nature.
•Disc complaints.
•Spondylo-arthrosis.
•Osteoporosis related lumbar vertebrae complaints.
•Para-vertebral lumbar muscle spasm.
•Light trauma of the lumbar-sacral column.
Recommended for general back pain and support.
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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33031 | Lumbar spine orthosis |
A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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IQE | Orthosis, Lumbar |
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
e8780595-2ace-4481-9903-8e183f1b8c3b
March 01, 2024
1
February 22, 2024
March 01, 2024
1
February 22, 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 |
---|---|---|---|---|---|
05391512286392 | 10 | 05391512282813 | In Commercial Distribution | Box Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
866-374-4050
contact@m-brace.com
contact@m-brace.com