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…

Registry build 21.09.26

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.

137manufacturers in China registered for this device type
42catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code ITQ
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

Regulatory record for M-Brace Air
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

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 numbers for M-Brace Air
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

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer