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M-Brace Air

FDA UDI

Class I (US FDA UDI)

by Indaco Srl

Identity

Trade Name
M-Brace Air FDA UDI
Generic Name
Knee support orthosis FDA UDI
Device Name
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 FDA UDI
Model / Reference
43 L FDA UDI
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 FDA UDI

Identifiers

Catalog Number
43 FDA UDI
Primary DI / UDI-DI
05391512281885 FDA UDI
FDA Product Code
ITQ FDA UDI
GMDN Term
Knee support orthosis FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3475 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Knee support orthosis

M-Brace Air by Indaco Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Knee support orthosis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Indaco Srl

Sources (1)

  • FDA UDI 372a0b3d-4e42-456a-a36b-1bbc21ee12e2 35 fields · synced May 30, 2026