M-Brace Air
Basic Information
- Brand Name
- M-Brace Air
- Primary DI
- 05391512280741
- Version / Model
- 573 S
- Catalog Number
- 573
- Company Name
- INDACO SRL
- Labeler DUNS
- 338470646
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-22
- Public Version
- 1
- Public Version Date
- 2024-03-01
- Public Version Status
- New
- Public Device Record Key
- 888aeed6-af67-42bb-950f-8538aca3065c
Device Description
This Lumblock 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 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. Practical and easy to wear, this Lumblock back 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. The Extra-Lumblock back brace model (#573) carry two additional sleeves at the back where custom moldable, anodized aluminum stays have been inserted. Although the rigidity of these braces has been remarkably increased, the comfort characteristics remain unaltered. INDICATIONS Disc complaints. Spondylo-arthrosis. Osteoporosis related lumbar vertebrae complaints. Para-vertebral lumbar muscle spasm. Light trauma of the lumbar-sacral column. 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. Breathable and non allergenic, 100% cotton Back is 13” high Front is 8” high
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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IQE | Orthosis, Lumbar | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05391512285548 | GS1 | Box Case | 15 | In Commercial Distribution | |
| Primary | 05391512280741 | GS1 |
Customer Contacts
- Phone
- 866-374-4050
- [email protected]