M-Brace Air
- Primary DI
- 05391512281892
- Brand
- M-Brace Air
- Company
- INDACO SRL
- Model
- 43 XL
- Catalog number
- 43
- Device description
- The Vega Aligner #43 knee brace with Range of motion (ROM) is designed to stabilize the motion of the knee joint, keeping it aligned during flexion and extension movements. Constructed entirely from breathable materials, the next-to-skin layer is made from anti-bacterial and anti-allergy fabric. Its complex structure, equipped with patella stabilizer, offers comfortable containment of the patellar compartment, useful in cases of associated conditions (medial or lateral ligaments, anterior or posterior cruciate ligament and patellar instability). Two patented, multicentric, adjustable aluminum rods are included to control flexion and extension quickly and easily. The rods are equipped with bearings supporting the condyles and rigid tibial and femoral supports to control rotation. L1832 or L1833 approved.INDICATIONSA knee orthosis with adjustable knee joints used for:• Patellar chonodropathy (osteochondral repairs)• Retropatellar osteoarthitis• Post-operative and post-traumatic irritations including rehabilitation of: MCL, LCL, PCL, ACL (Sprains, Meniscus injuries, Lateral, Anterior, Medial & Posterior tilt, etc.)• Post lateral release surgery to limit the extension and flexion of the joint• Patella and knee instabilities (Patella Dislocation, Patella Subluxation, Patella Alta, Patella stabilization, Patella tendon repairs)• General knee pain• Mild Chondromalacia• Condylar Fractures• Tibial Plateau Fractures
- Published
- 2024-02-13
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| ITQ | Joint, Knee, External Brace |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| ITQ | Joint, Knee, External Brace | Physical Medicine | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05391512286705 | Package | GS1 | 6 | In Commercial Distribution |
| 05391512281892 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05391512286705 | 05391512286705 | 5391512286705 |
| 05391512281892 | 05391512281892 | 5391512281892 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Contacts#
| Phone | |
|---|---|
| 1-866-374-4050 | contact@m-brace.com |
Regulatory Flags#
- DUNS number
- 338470646
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 05391512281021 | M-Brace Air | 576 S | 576 | 2024-02-15 |
| 05391512281038 | M-Brace Air | 576 M | 576 | 2024-02-15 |
| 05391512281045 | M-Brace Air | 576 L | 576 | 2024-02-15 |
| 05391512281052 | M-Brace Air | 576 XL | 576 | 2024-02-15 |
| 05391512281441 | M-Brace Air | 576 XXL | 576 | 2024-02-15 |
| 05391512282905 | HPH Corp. | 648K size 26 | 648K | 2024-04-04 |
| 05391512282912 | HPH Corp. | 648K size 28 | 648K | 2024-04-04 |
| 05391512282929 | HPH Corp. | 648K size 30 | 648K | 2024-04-04 |
| 05391512282936 | HPH Corp. | 648K size 32 | 648K | 2024-04-04 |
| 05391512282943 | HPH Corp. | 648K size 34 | 648K | 2024-04-04 |
| 05391512282950 | HPH Corp. | 648K size 36 | 648K | 2024-04-04 |
| 05391512282967 | HPH Corp. | 648K size 38 | 648K | 2024-04-04 |
| 05391512282974 | HPH Corp. | 648K size 40 | 648K | 2024-04-04 |
| 05391512282981 | HPH Corp. | 648K size 42 | 648K | 2024-04-04 |
| 05391512282998 | HPH Corp. | 648K size 44 | 648K | 2024-04-04 |
| 05391512283001 | HPH Corp. | 648K size 46 | 648K | 2024-04-04 |
| 05391512283018 | HPH Corp. | 648K size 48 | 648K | 2024-04-04 |
| 05391512283025 | HPH Corp. | 648K size 50 | 648K | 2024-04-04 |
| 05391512283032 | HPH Corp. | 648K size 52 | 648K | 2024-04-04 |
| 05391512283049 | HPH Corp. | 648K size 54 | 648K | 2024-04-04 |
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