FDA UDI In Commercial Distribution 🇺🇸 United States

M-Brace Air

DI: 05391512282271 · Model: 631 2XL/3XL · INDACO SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
M-Brace Air
Primary DI
05391512282271
Version / Model
631 2XL/3XL
Catalog Number
631
Company Name
INDACO SRL
Labeler DUNS
338470646
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-01-30
Public Version
1
Public Version Date
2024-02-07
Public Version Status
New
Public Device Record Key
dd48c1f8-9af2-4053-95ec-aad5ba90bc03

Device Description

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.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IPY Orthosis, Lumbo-Sacral

GMDN Terms

Code Name
33031 Lumbar spine orthosis

Identifiers

Type ID
Package 05391512286231
Primary 05391512282271

Customer Contacts