M-Brace Air
- Primary DI
- 05391512286750
- Brand
- M-Brace Air
- Company
- INDACO SRL
- Model
- 46 RM
- Catalog number
- 46
- Device description
- The OA (Osteoarthritis) Knee Brace with Range of Motion (#46) brings your comfort to a new level with its elegant and light design. Available for the right or left knee, this brace alleviates knee pain by reducing the weight on your medial or lateral compartment by using the three-point pressure system. It is composed of two aluminum reinforced semi-rigid straps that surround the distal region (above the knee) and the proximal region (below the knee). These straps are to be custom molded to allow for an optimal torsion support. Additionally, these straps are bound together by a patented articulated aluminum support that is easily adjustable for flexion and extension and accessible within a zipped pocket. The patient can adjust the amount of lateral pressure applied by choosing between two different buttress (cushion) thicknesses. The high surface of the brace’s sleeve allows for comfortable support around the affected joint. The patellar support on this brace is easy and simple to use and allows for a straightforward fitting of the product. Should you need to mold the brace to certain specifications or simply to wash the sleeve, the articulated support could be easily removed by unzipping the brace (see instructions). INDICATIONS: Use this knee brace for the following indications: • Mild to moderate medial compartment OA without instability. • Meniscus procedures. • Chondral defect procedures. • Moderate lateral compartment OA without instability; it is possible to reduce the load on the lateral compartment by using a “right” brace on a left leg or a “left” brace on a right leg.
- Published
- 2024-02-12
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- true
- Sterile
- false
- Single use
- false
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 |
|---|---|---|---|---|
| 05391512286750 | Package | GS1 | 6 | In Commercial Distribution |
| 05391512282097 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05391512286750 | 05391512286750 | 5391512286750 |
| 05391512282097 | 05391512282097 | 5391512282097 |
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. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 1-866-374-4050 | contact@m-brace.com |
Regulatory Flags#
- DUNS number
- 338470646
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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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| 00609271610798 | "Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610804 | "Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (x-large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
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