Identity
- Trade Name
- M-Brace Air FDA UDI
- Generic Name
- Elbow orthosis FDA UDI
- Device Name
- This Epicondylitis Brace (Tennis / Golfers Elbow brace) has been designed and produced as a support and protective device for tendon and joint inflammations either caused by 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 should be adjusted taking care not to slow down the normal circulation of blood. The pressure of the inside pad, which needs to be positioned immediately below the insertion of the tendon, relieves pain by diminishing the stress on muscles, tendons and ligaments. FDA UDI
- Model / Reference
- 139 R FDA UDI
- Description
- This Epicondylitis Brace (Tennis / Golfers Elbow brace) has been designed and produced as a support and protective device for tendon and joint inflammations either caused by 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 should be adjusted taking care not to slow down the normal circulation of blood. The pressure of the inside pad, which needs to be positioned immediately below the insertion of the tendon, relieves pain by diminishing the stress on muscles, tendons and ligaments. FDA UDI
Identifiers
- Catalog Number
- 139 FDA UDI
- Primary DI / UDI-DI
- 05391512281922 FDA UDI
- FDA Product Code
- IQI FDA UDI
- GMDN Term
- Elbow 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
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: Elbow orthosis
M-Brace Air by Indaco Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Indaco Srl
Sources (1)
- FDA UDI 1ce97d19-614f-4c13-aac1-63689fa0e471 35 fields · synced May 30, 2026