M-Brace Air
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…
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.
Who Else Makes It
Concentrated in Guangdong (35), Jiangsu (33), Zhejiang (18). 30 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Xiamen Ortocare Sports Health Co., Ltd. | Xiamen Free Trade Zone | Fujian | Contract manufacturer | 32 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Beijing Jinwei Kangda Medical Instrument Ltd. | Langfang | Hebei | Contract manufacturer | 21 |
| Hengshui Xukang Medical Appliances Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 21 |
| Wenzhou Zuoyou Medical Technoloyg Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 21 |
| Foshan Huafukang Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 19 |
| Wellpower Sporting Goods Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 18 |
| Anhui Kangfu Industrial Foreign Trade Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 18 |
Showing 12 of 137. All 137 manufacturers in China registered for Joint, Knee, External Brace
Record
| Listed by | Indaco SRL |
|---|---|
| FDA product code | ITQ |
| Device type | Joint, Knee, External Brace |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| Premarket notification | Exempt |
| Record published | 2024-02-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Box case of 10, box case of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 46 RS | In distribution | |
| 75 XL | In distribution | |
| 75 M | In distribution | |
| 43 L | In distribution | |
| 40 XS | In distribution | |
| 40 XL | In distribution | |
| 46 RM | In distribution | |
| 41 L | In distribution | |
| 46 RXL | In distribution | |
| 41 XS | In distribution | |
| 46 RXXL | In distribution | |
| 75 XS | In distribution | |
| 43 XXL | In distribution | |
| 40 S | In distribution | |
| 43 XS | In distribution | |
| 41 3XL | In distribution | |
| 43 M | In distribution | |
| 41 S | In distribution | |
| 46 LXL | In distribution | |
| 43 XL | In distribution | |
| 40 XXL | In distribution | |
| 75 XXL | In distribution | |
| 40 4XL | In distribution | |
| 43 3XL | In distribution | |
| 41 M | In distribution | |
| 41 XL | In distribution | |
| 75 L | In distribution | |
| 46 LXXL | In distribution | |
| 75 S | In distribution | |
| 46 LS | In distribution | |
| 40 M | In distribution | |
| 41 4XL | In distribution | |
| 66T | In distribution | |
| 75 4XL | In distribution | |
| 46 LM | In distribution | |
| 46 LL | In distribution | |
| 43 S | In distribution | |
| 41 XXL | In distribution | |
| 75 3XL | In distribution | |
| 40 L | In distribution | |
| 46 RL | In distribution | |
| 40 XXXL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 987 |
| Medi | Medi Manufacturing Inc | 413 |
| Vive | Vive Health LLC | 122 |
| Donjoy Performance | DJO, LLC | 107 |
| CoreTech | Vive Health LLC | 105 |
| NON Franchise | DJO, LLC | 61 |
| Gripper Hinged Knee | Medical Specialties, Inc. | 46 |
| ManaMed | Manamed LLC | 46 |
| Profit | Pantymed S.A. | 46 |
| Copperfit | Ideavillage Products Corp. | 42 |
| Joint, Knee, External Brace | Tetra Medical Supply Corp. | 35 |
| BMI | Blake Manufacturing, Inc. | 34 |
Showing 12 of 507. All products under Joint, Knee, External Brace
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.