Identity
- Trade Name
- M-Brace Air FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDI
- Device Name
- The Salto Ankle Stabilizer Brace is made with an exclusive, hypo- allergenic and breathable fabric, resulting from a careful research and selection of materials, as well as the use of a unique construction technology, this innovative ankle stabilizer combines the ease of use of a mass-produced item with the effectiveness of a taping bandage. It is the only ankle brace with a posterior opening, allowing easy and painless application The brace offers a constant control of the inversion and eversion degree. Far from being cumbersome, it can easily fit any shoe and can be worn on either foot. INDICATIONS • Traumatic pathologies: distortions – tendonitis – luxations. • Rehab phase: passive support for the ankle functional rehab, it controls inversion and eversion movements of the ankle. FDA UDI
- Model / Reference
- 17 L FDA UDI
- Description
- The Salto Ankle Stabilizer Brace is made with an exclusive, hypo- allergenic and breathable fabric, resulting from a careful research and selection of materials, as well as the use of a unique construction technology, this innovative ankle stabilizer combines the ease of use of a mass-produced item with the effectiveness of a taping bandage. It is the only ankle brace with a posterior opening, allowing easy and painless application The brace offers a constant control of the inversion and eversion degree. Far from being cumbersome, it can easily fit any shoe and can be worn on either foot. INDICATIONS • Traumatic pathologies: distortions – tendonitis – luxations. • Rehab phase: passive support for the ankle functional rehab, it controls inversion and eversion movements of the ankle. FDA UDI
Identifiers
- Catalog Number
- 17 FDA UDI
- Primary DI / UDI-DI
- 05391512280208 FDA UDI
- FDA Product Code
- ITW FDA UDI
- GMDN Term
- Ankle/foot 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: Ankle/foot 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 bef8b9fb-72ca-4bdf-bef4-8b70df30b102 35 fields · synced Jun 1, 2026