M-Brace Air 594

GUDID 05391512285913

The Light M-Spine LSO (#594) 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 L-1 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. INDICATIONS Lumbago, sciatica Lumbar-Sacral pain of other origin and nature. Disc complaints. Spondylarthrosis; osteoarthritis of the spine. Osteoporosis related lumbar vertebrae complaints. Para-vertebral lumbar muscle spasm. Light trauma of the lumbar-sacral column. This corset acts as a corrective measure and as a support to postural defects. Breathable and non-allergenic, 100% cotton.

INDACO SRL

Lumbar spine orthosis Lumbar spine orthosis Lumbar spine orthosis Lumbar spine orthosis Lumbar spine orthosis Lumbar spine orthosis Lumbar spine orthosis Lumbar spine orthosis Lumbar spine orthosis Lumbar spine orthosis Lumbar spine orthosis Lumbar spine orthosis Lumbar spine orthosis Lumbar spine orthosis Lumbar spine orthosis Lumbar spine orthosis Lumbar spine orthosis
Primary Device ID05391512285913
NIH Device Record Key38195159-d964-4f91-886c-14a30bebdc92
Commercial Distribution StatusIn Commercial Distribution
Brand NameM-Brace Air
Version Model Number594 XL
Catalog Number594
Company DUNS338470646
Company NameINDACO SRL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-866-374-4050
Emailcontact@m-brace.com
Phone1-866-374-4050
Emailcontact@m-brace.com
Phone1-866-374-4050
Emailcontact@m-brace.com
Phone1-866-374-4050
Emailcontact@m-brace.com
Phone1-866-374-4050
Emailcontact@m-brace.com
Phone1-866-374-4050
Emailcontact@m-brace.com
Phone1-866-374-4050
Emailcontact@m-brace.com
Phone1-866-374-4050
Emailcontact@m-brace.com
Phone1-866-374-4050
Emailcontact@m-brace.com
Phone1-866-374-4050
Emailcontact@m-brace.com
Phone1-866-374-4050
Emailcontact@m-brace.com
Phone1-866-374-4050
Emailcontact@m-brace.com
Phone1-866-374-4050
Emailcontact@m-brace.com
Phone1-866-374-4050
Emailcontact@m-brace.com
Phone1-866-374-4050
Emailcontact@m-brace.com
Phone1-866-374-4050
Emailcontact@m-brace.com
Phone1-866-374-4050
Emailcontact@m-brace.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105391512281397 [Primary]
GS105391512285913 [Package]
Contains: 05391512281397
Package: Box Case [10 Units]
In Commercial Distribution

FDA Product Code

IPYOrthosis, Lumbo-Sacral

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-05
Device Publish Date2024-01-26

On-Brand Devices [M-Brace Air]

05391512286378The Blue Line M-Brace Lumbar-Sacral Brace acts as an immobilizing device for the lumbar-sacral r
05391512286361The Blue Line M-Brace Lumbar-Sacral Brace acts as an immobilizing device for the lumbar-sacral r
05391512286354The Blue Line M-Brace Lumbar-Sacral Brace acts as an immobilizing device for the lumbar-sacral r
05391512286347The Blue Line M-Brace Lumbar-Sacral Brace acts as an immobilizing device for the lumbar-sacral r
05391512286330The Blue Line M-Brace Lumbar-Sacral Brace acts as an immobilizing device for the lumbar-sacral r
05391512286323The Blue Line M-Brace Lumbar-Sacral Brace acts as an immobilizing device for the lumbar-sacral r
05391512286194The AIR Back Brace Low Profile acts as an immobilizing device for the lumbar-sacral region and i
05391512286187The AIR Back Brace Low Profile acts as an immobilizing device for the lumbar-sacral region and i
05391512286170The AIR Back Brace Low Profile acts as an immobilizing device for the lumbar-sacral region and i
05391512285623The M-Spine LSO Back Brace (#574) consists of 5 separate pieces: A corset fitted with 8 flexible
05391512285791The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her r
05391512285937The Light M-Spine LSO (#594) acts as an immobilizing device for the lumbar-sacral region and its
05391512285920The Light M-Spine LSO (#594) acts as an immobilizing device for the lumbar-sacral region and its
05391512285913The Light M-Spine LSO (#594) acts as an immobilizing device for the lumbar-sacral region and its
05391512285906The Light M-Spine LSO (#594) acts as an immobilizing device for the lumbar-sacral region and its
05391512285890The Light M-Spine LSO (#594) acts as an immobilizing device for the lumbar-sacral region and its
05391512285883The Light M-Spine LSO (#594) acts as an immobilizing device for the lumbar-sacral region and its
05391512285869The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her r
05391512285852The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her r
05391512281106The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her r
05391512285838The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her r
05391512285821The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her r
05391512285814The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her r
05391512285807The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her r
05391512285692The M-Spine LSO Back Brace (#574) consists of 5 separate pieces: A corset fitted with 8 flexible
05391512285685The M-Spine LSO Back Brace (#574) consists of 5 separate pieces: A corset fitted with 8 flexible
05391512285678The M-Spine LSO Back Brace (#574) consists of 5 separate pieces: A corset fitted with 8 flexible
05391512285661The M-Spine LSO Back Brace (#574) consists of 5 separate pieces: A corset fitted with 8 flexible
05391512285654The M-Spine LSO Back Brace (#574) consists of 5 separate pieces: A corset fitted with 8 flexible
05391512285647The M-Spine LSO Back Brace (#574) consists of 5 separate pieces: A corset fitted with 8 flexible
05391512285630The M-Spine LSO Back Brace (#574) consists of 5 separate pieces: A corset fitted with 8 flexible
05391512285098The ankle brace Strenua – Extra Ankle Lock (#16) is recommended for the diagnosis: Posterior T
05391512285081The ankle brace Strenua – Extra Ankle Lock (#16) is recommended for the diagnosis: Posterior T
05391512285074The ankle brace Strenua – Extra Ankle Lock (#16) is recommended for the diagnosis: Posterior T
05391512285067The ankle brace Strenua – Extra Ankle Lock (#16) is recommended for the diagnosis: Posterior T
05391512285050The ankle brace Strenua – Extra Ankle Lock (#16) is recommended for the diagnosis: Posterior T
05391512285043The Mercurio Ankle Lock brace, with elastic, reinforced strap to be applied to the ankle using o
05391512282455This one size fits all Lumbar sacral orthosis as an immobilizing device for the lumbar-sacral re
05391512282431This Lumbar sacral orthosis as an immobilizing device for the lumbar-sacral region and its’ pr
05391512286316The AIR Back Brace Low Profile acts as an immobilizing device for the lumbar-sacral region and i
05391512286309The AIR Back Brace Low Profile acts as an immobilizing device for the lumbar-sacral region and i
05391512286293The AIR Back Brace Low Profile acts as an immobilizing device for the lumbar-sacral region and i
05391512286279This Lumbar-Sacral Brace acts as an immobilizing device for the lumbar-sacral region and its’
05391512286262This Lumbar-Sacral Brace acts as an immobilizing device for the lumbar-sacral region and its’
05391512286255This Lumbar-Sacral Brace acts as an immobilizing device for the lumbar-sacral region and its’
05391512286231The AIR Back Brace Low Profile acts as an immobilizing device for the lumbar-sacral region and i
05391512286224The AIR Back Brace Low Profile acts as an immobilizing device for the lumbar-sacral region and i
05391512286217The AIR Back Brace Low Profile acts as an immobilizing device for the lumbar-sacral region and i
05391512285142The Salto Ankle Stabilizer Brace is made with an exclusive, hypo- allergenic and breathable fabr
05391512285135The Salto Ankle Stabilizer Brace is made with an exclusive, hypo- allergenic and breathable fabr

Trademark Results [M-Brace Air]

Mark Image

Registration | Serial
Company
Trademark
Application Date
M-BRACE AIR
M-BRACE AIR
86082065 5022891 Live/Registered
Indaco S.r.l.
2013-10-03

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