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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
Vega Patella Stabilizer Knee brace is for both right and left knees providing optimal support and protection following muscle, joint or tendon injuries in the region of the patella. Constructed exclusively from breathable hypoallergenic fabrics (Neoprene-free and Latex-free), the area which comes into contact with the skin is made of soft 100% cotton. An exclusive handy locking system allows the required pressure to be varied in three different areas. Featuring two unique C-shaped pressure pads which, when brought together as the brace is secured, surround and stabilize the patella. 2 low profile 2 mm super light rods, to keep the brace in place 2 replacement super light rods (for product 40 only) 2 multi-centric molded aluminum hinges (LATERAL and MEDIAL, product 41 only) for improved lateral support in cases of patella related pathologies associated with minor instability of medial and/or lateral collateral ligaments. INDICATIONS • Traumatic pathologies: instability of the patella, sub-dislocations of the patella, femur-patella arthrosis, fractures of the patella, post op (associated pathologies, patella + minor instability of collateral ligaments; MCL and LCL – product 41 only) • Rehabilitation phase: provides passive support during rehabilitation, provides protection during sporting activities. General overall knee pain. FDA UDI
Model / Reference
41 M FDA UDI
Description
Vega Patella Stabilizer Knee brace is for both right and left knees providing optimal support and protection following muscle, joint or tendon injuries in the region of the patella. Constructed exclusively from breathable hypoallergenic fabrics (Neoprene-free and Latex-free), the area which comes into contact with the skin is made of soft 100% cotton. An exclusive handy locking system allows the required pressure to be varied in three different areas. Featuring two unique C-shaped pressure pads which, when brought together as the brace is secured, surround and stabilize the patella. 2 low profile 2 mm super light rods, to keep the brace in place 2 replacement super light rods (for product 40 only) 2 multi-centric molded aluminum hinges (LATERAL and MEDIAL, product 41 only) for improved lateral support in cases of patella related pathologies associated with minor instability of medial and/or lateral collateral ligaments. INDICATIONS • Traumatic pathologies: instability of the patella, sub-dislocations of the patella, femur-patella arthrosis, fractures of the patella, post op (associated pathologies, patella + minor instability of collateral ligaments; MCL and LCL – product 41 only) • Rehabilitation phase: provides passive support during rehabilitation, provides protection during sporting activities. General overall knee pain. FDA UDI

Identifiers

Catalog Number
41 FDA UDI
Primary DI / UDI-DI
05391512280376 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 71260143-09ad-423e-89a0-a80c63a1fa2c 35 fields · synced Jun 6, 2026