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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 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. FDA UDI
Model / Reference
46 RL FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
46 FDA UDI
Primary DI / UDI-DI
05391512282103 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 6d00a9ca-4e25-4570-b852-c089763592e6 35 fields · synced Jun 7, 2026