Identity
- Trade Name
- M-Brace Air FDA UDI
- Generic Name
- Knee support orthosis FDA UDI
- Device Name
- The Knee Wrap is used as a protective support following muscular, articular or ligament injuries of the patellar region. Two different materials were used in its construction; the inside is made of soft cotton velour that is breathable and does not cause skin irritation and the outside is a special nylon that permits the Velcro to grip and stay fastened. Recommended for overall general knee pain. INDICATIONS • Support and compression for light patellar trauma. • Easy adjustments superior to patella or inferior to the patella, depending on the degree of compression needed. • Completely adjustable, two sizes only. • Neoprene and Latex free. FDA UDI
- Model / Reference
- 20 R FDA UDI
- Description
- The Knee Wrap is used as a protective support following muscular, articular or ligament injuries of the patellar region. Two different materials were used in its construction; the inside is made of soft cotton velour that is breathable and does not cause skin irritation and the outside is a special nylon that permits the Velcro to grip and stay fastened. Recommended for overall general knee pain. INDICATIONS • Support and compression for light patellar trauma. • Easy adjustments superior to patella or inferior to the patella, depending on the degree of compression needed. • Completely adjustable, two sizes only. • Neoprene and Latex free. FDA UDI
Identifiers
- Catalog Number
- 20 FDA UDI
- Primary DI / UDI-DI
- 05391512280253 FDA UDI
- FDA Product Code
- FQM FDA UDI
- GMDN Term
- Knee support orthosis 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: Knee support orthosis
M-Brace Air by Indaco Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
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- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
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 9da3bd7b-5a18-44ab-b3bd-6aee75624e77 35 fields · synced May 30, 2026