DEVICE: M-Brace Air (05391512282332)

Device Identifier (DI) Information

M-Brace Air
630 S/M
In Commercial Distribution
630
INDACO SRL
05391512282332
GS1

1
338470646 *Terms of Use
The AIR Back Brace Low Profile acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago and sciatica. Made with semi-rigid cotton fabric, it enjoys a structure made with eight self-modeling and flexible steel 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 immobilizing the lumbar-sacral region. Two rigid thermo-formable panels for lumbar and abdominal application 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. The supported region extends from the sacrococcygeal joint to T-9 vertebra. 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 elastic tension settings. This patented immobilizing device can be adapted to the patient’s size and body type thus resulting in a custom device. Two preliminary settings: a) for different waist or pelvis circumferences (usually only in S/M size) b) for different sizes. 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. • Supports from sacrum to T-9 level. • Post-op: Following stabilizing surgery, following lumbar disk surgery. • Degenerative pathologies: Osteoporosis, lumbar- sacral vertebrae complaint, protrusions, arthritis. • Muscular pathologies: Muscular contractures. • Practical and easy to fit, it adapts perfectly to your body. • This corset acts as a corrective measure and as a support to postural defects.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
Yes
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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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
IPY Orthosis, Lumbo-Sacral
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

11e5f003-fd27-49e1-a534-40e5bfd5bf67
February 07, 2024
1
January 30, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05391512286293 10 05391512282332 In Commercial Distribution Box Case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

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1-866-374-4050
contact@m-brace.com
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