M-Brace Air

Basic Information

• Brand Name: M-Brace Air
• Primary DI: 05391512282134
• Version / Model: 43 3XL
• Catalog Number: 43
• Company Name: INDACO SRL
• Labeler DUNS: 338470646
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-13
• Public Version: 1
• Public Version Date: 2024-02-21
• Public Version Status: New
• Public Device Record Key: 6ebf9d37-f11d-4af1-b0c7-d62bb2f01741

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. INDICATIONS A 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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITQ	Joint, Knee, External Brace	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41065	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05391512286729	GS1	Box Case	6	In Commercial Distribution
Primary	05391512282134	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]