Identity
- Trade Name
- M-Brace Air FDA UDI
- Generic Name
- Ankle binder, reusable FDA UDI
- Device Name
- The ankle brace Strenua – Extra Ankle Lock (#16) is recommended for the diagnosis: Posterior Tibial Tendon Dysfunction; Plantar Fasciitis ; Peroneal tendon instability General mild ankle instability. Indications are: Traumatic pathologies: dislocations – distortions and sub-luxation of the ankle; Rehab phase: passive support for the ankle during late functional rehab phase.: Strongly indicated for use during sport, prevents excessive pronation / supination of the ankle. Thanks to the use of an exclusive, hypo- allergenic and breathable fabric, resulting from a careful research and selection of materials, as well as to the use of a unique construction technology, this ankle-support is extremely comfortable and easy to use. Small sized, it can easily fit any shoe. It can be worn on either foot. Neoprene and latex free. FDA UDI
- Model / Reference
- 16 M FDA UDI
- Description
- The ankle brace Strenua – Extra Ankle Lock (#16) is recommended for the diagnosis: Posterior Tibial Tendon Dysfunction; Plantar Fasciitis ; Peroneal tendon instability General mild ankle instability. Indications are: Traumatic pathologies: dislocations – distortions and sub-luxation of the ankle; Rehab phase: passive support for the ankle during late functional rehab phase.: Strongly indicated for use during sport, prevents excessive pronation / supination of the ankle. Thanks to the use of an exclusive, hypo- allergenic and breathable fabric, resulting from a careful research and selection of materials, as well as to the use of a unique construction technology, this ankle-support is extremely comfortable and easy to use. Small sized, it can easily fit any shoe. It can be worn on either foot. Neoprene and latex free. FDA UDI
Identifiers
- Catalog Number
- 16 FDA UDI
- Primary DI / UDI-DI
- 05391512280147 FDA UDI
- FDA Product Code
- FQM FDA UDI
- GMDN Term
- Ankle 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: Ankle binder, reusable
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 1aaf4574-cbc5-4a7d-9f7f-79f6bc913441 35 fields · synced May 30, 2026