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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
Telescopic Post-Operative Knee Brace (#66T) This medical device is a Post-Op Knee brace with articulated telescopic bars in light aluminium alloy, padded by soft MTP and sponge fabric in contact with skin to reduce sweating. It has separate bands in order to ensure greater breathability of the leg and valves for belts specially designed to reduce the pressure of the bands. It also has adjustable strap closures that insures the orthosis is tightly secured to the limb. The knee brace has a Range of Motion Joint, adjustment of flexion and extension at 10° (flexion 0° / 120°; extension 0° / 90°) and an option to block joint every 10°. It contains condylar protective detachable pads. Its shape provides an excellent anatomic stabilization of the limb and comfortable to wear and use. One size fits all. L1832 or L1833 approved. INDICATIONS Post-operative knee ligament reconstruction treatment, complete prosthesis, femoral or tibia fractures at the knee, valgus and varus osteotomy. Recommended to treat post-traumatic knee strain requiring semi-flexion immobilization. FDA UDI
Model / Reference
66T FDA UDI
Description
Telescopic Post-Operative Knee Brace (#66T) This medical device is a Post-Op Knee brace with articulated telescopic bars in light aluminium alloy, padded by soft MTP and sponge fabric in contact with skin to reduce sweating. It has separate bands in order to ensure greater breathability of the leg and valves for belts specially designed to reduce the pressure of the bands. It also has adjustable strap closures that insures the orthosis is tightly secured to the limb. The knee brace has a Range of Motion Joint, adjustment of flexion and extension at 10° (flexion 0° / 120°; extension 0° / 90°) and an option to block joint every 10°. It contains condylar protective detachable pads. Its shape provides an excellent anatomic stabilization of the limb and comfortable to wear and use. One size fits all. L1832 or L1833 approved. INDICATIONS Post-operative knee ligament reconstruction treatment, complete prosthesis, femoral or tibia fractures at the knee, valgus and varus osteotomy. Recommended to treat post-traumatic knee strain requiring semi-flexion immobilization. FDA UDI

Identifiers

Catalog Number
66T FDA UDI
Primary DI / UDI-DI
05391512284350 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 b5f7b354-182b-4ad4-bd9d-bae629db6ba2 35 fields · synced Jun 8, 2026