M-Brace Air

Made of an elastic fabric, the CLAVICLE SUPPORT is comfortable and easy to put on. It is composed of two bands to be worn on the right and left shoulder, crossed behind the back and then…

Registry build 21.09.26

Made of an elastic fabric, the CLAVICLE SUPPORT is comfortable and easy to put on. It is composed of two bands to be worn on the right and left shoulder, crossed behind the back and then locked together on the abdomen at the desired tightness. The constant support of the shoulders relaxes the pectoral muscles and improves posture. To ensure maximum comfort especially during extended use, this product was made with a breathable fabric. INDICATIONS • Rigid or falling shoulders • Bad posture • Clavicle injuries

8manufacturers in China registered for this device type
5catalogue numbers in this listing

Who Else Makes It

Concentrated in Fujian (4), Shanghai (2), Anhui (1).

Chinese manufacturers registered for FDA product code NJB
Manufacturer City Province Registered as Device types
Planet(Shanghai) International Co., Ltd. Shanghai Shanghai Exporter 93
Planet (Anhui) International Co., Ltd. Chuzhou Anhui Exporter 80
AID United International Co., Limited Shanghai Shanghai Specification developer 65
Orthotech Rehabilitation Co., Ltd. Xiamen Fujian Manufacturer 26
Zhangzhou Recaring Medical Instrument Co., Ltd. Zhangzhou Fujian Manufacturer 24
Abletech Orthopedics Corporation New Taipei Taiwan Contract manufacturer 21
Liven Sports MFG. (Xiamen) Co., Ltd. Xiamen Fujian Manufacturer 21
Zhangpu Ortholife Rehabilitation Co., Ltd. Zhangzhou Fujian Manufacturer 21

Record

Regulatory record for M-Brace Air
Listed by Indaco SRL
FDA product code NJB
Device type Orthosis, Truncal, For Dysmenorrhea
Device class Class 1
Regulation 21 CFR 890.3490
Premarket notification Exempt
Record published 2024-02-15
Record revised 2024-08-20 (version 2)

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

Catalogue Numbers

Catalogue numbers for M-Brace Air
Catalogue number Size Status
576 S In distribution
576 M In distribution
576 L In distribution
576 XXL In distribution
576 XL In distribution

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