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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 Knee Brace # 75 Artemis Light MCL-LCL Instability is for both right and left knees providing optimal support and protection following muscle, joint and/or tendon injuries, LCL MCL weakness. It is constructed exclusively from breathable hypoallergenic fabrics (neoprene 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 two different areas - 2 molded aluminum hinges (lateral and medial) for optimal lateral support- 2 low profile 2mm super light rods, to keep the brace in place during compression therapy. Indications ° Traumatic pathologies: light distortions, light articular laxity, bursitis, articular effusion. ° Rehab phase: passive support during rehab, light protection during sports. ° Offers compression and slight re- alignment in the presence of mild osteorthratis ° Anatomically shaped medial and lateral aluminum polycentric hinges guarantee a complete synchrony with the natural movement of the knee. ° Breathable, 100% cotton on your skin. FDA UDI
Model / Reference
75 XS FDA UDI
Description
The Knee Brace # 75 Artemis Light MCL-LCL Instability is for both right and left knees providing optimal support and protection following muscle, joint and/or tendon injuries, LCL MCL weakness. It is constructed exclusively from breathable hypoallergenic fabrics (neoprene 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 two different areas - 2 molded aluminum hinges (lateral and medial) for optimal lateral support- 2 low profile 2mm super light rods, to keep the brace in place during compression therapy. Indications ° Traumatic pathologies: light distortions, light articular laxity, bursitis, articular effusion. ° Rehab phase: passive support during rehab, light protection during sports. ° Offers compression and slight re- alignment in the presence of mild osteorthratis ° Anatomically shaped medial and lateral aluminum polycentric hinges guarantee a complete synchrony with the natural movement of the knee. ° Breathable, 100% cotton on your skin. FDA UDI

Identifiers

Catalog Number
75 FDA UDI
Primary DI / UDI-DI
05391512280437 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 3e0e0814-952b-46dc-bb57-08c4d96d16b9 35 fields · synced May 30, 2026