M-Brace Air
Basic Information
- Brand Name
- M-Brace Air
- Primary DI
- 05391512280352
- Version / Model
- 41 XS
- Catalog Number
- 41
- Company Name
- INDACO SRL
- Labeler DUNS
- 338470646
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-13
- Public Version
- 1
- Public Version Date
- 2024-02-21
- Public Version Status
- New
- Public Device Record Key
- fc7c06d9-8329-4aa8-b91b-31750737bf24
Device Description
Vega Patella Stabilizer Knee brace is for both right and left knees providing optimal support and protection following muscle, joint or tendon injuries in the region of the patella. Constructed exclusively from breathable hypoallergenic fabrics (Neoprene-free and Latex-free), the area which comes into contact with the skin is made of soft 100% cotton. An exclusive handy locking system allows the required pressure to be varied in three different areas. Featuring two unique C-shaped pressure pads which, when brought together as the brace is secured, surround and stabilize the patella. 2 low profile 2 mm super light rods, to keep the brace in place 2 replacement super light rods (for product 40 only) 2 multi-centric molded aluminum hinges (LATERAL and MEDIAL, product 41 only) for improved lateral support in cases of patella related pathologies associated with minor instability of medial and/or lateral collateral ligaments. INDICATIONS • Traumatic pathologies: instability of the patella, sub-dislocations of the patella, femur-patella arthrosis, fractures of the patella, post op (associated pathologies, patella + minor instability of collateral ligaments; MCL and LCL – product 41 only) • Rehabilitation phase: provides passive support during rehabilitation, provides protection during sporting activities. General overall knee pain.
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 |
|---|---|---|---|---|
| ITQ | Joint, Knee, External Brace | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41065 | Knee support orthosis | A stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05391512285272 | GS1 | Box Case | 10 | In Commercial Distribution | |
| Primary | 05391512280352 | GS1 |
Customer Contacts
- Phone
- 1-866-374-4050
- [email protected]