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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
Wrist binder, reusable FDA UDI
Device Name
This Wrist Support has been designed and produced as a support and protective device for muscular minor damages, as well as for tendon and joint inflammations either caused by light trauma, stress or excessive fatigue. For the development of this device, two special fabrics have been matched: • The inside fabric is made from a soft breathable microfiber, extremely comfortable to the skin. • The fabric on the outside, made with a particular and dense nylon mesh forming microscopic and resistant loops, allows the Velcro to securely fasten on the surface. Due to the specific construction, this brace can be worn and positioned very easily. The tension can be adjusted according to individual needs. NON-ELASTIC. Patented M-Brace technology. INDICATIONS • For light traumas and minor injuries of the wrist. • Post-trauma rehab and prevention during sports. Easily adjustable compression. • 100% breathable. • Patented M-Brace technology. • Neoprene and latex free. FDA UDI
Model / Reference
132 R FDA UDI
Description
This Wrist Support has been designed and produced as a support and protective device for muscular minor damages, as well as for tendon and joint inflammations either caused by light trauma, stress or excessive fatigue. For the development of this device, two special fabrics have been matched: • The inside fabric is made from a soft breathable microfiber, extremely comfortable to the skin. • The fabric on the outside, made with a particular and dense nylon mesh forming microscopic and resistant loops, allows the Velcro to securely fasten on the surface. Due to the specific construction, this brace can be worn and positioned very easily. The tension can be adjusted according to individual needs. NON-ELASTIC. Patented M-Brace technology. INDICATIONS • For light traumas and minor injuries of the wrist. • Post-trauma rehab and prevention during sports. Easily adjustable compression. • 100% breathable. • Patented M-Brace technology. • Neoprene and latex free. FDA UDI

Identifiers

Catalog Number
132 FDA UDI
Primary DI / UDI-DI
05391512281908 FDA UDI
FDA Product Code
FQM FDA UDI
GMDN Term
Wrist binder, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5075 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

No

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: Wrist binder, reusable

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

Similar devices

Also classified as Wrist binder, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Indaco Srl

Sources (1)

  • FDA UDI 4afe0a85-1945-4ced-8f66-5022db53e335 35 fields · synced May 29, 2026