Identity
- Trade Name
- M-Brace Air FDA UDI
- Generic Name
- Compression/pressure tubular garment FDA UDI
- Device Name
- The M-Brace #80 Thigh Wrap insures a constant pressure on the quadriceps and the hamstrings following muscle strains to alleviate pain and to shorten the healing process. Different materials were used in its construction among which two in particular; 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. The wrap can be perfectly adjusted. It comes with an inside pad that can be positioned in the exact place of injury. To ensure maximum comfort especially during extended use, this product was made with a breathable fabric. INDICATIONS Indicated for muscles strains (quad or femoral bicep). Alleviates pain by exerting a constant compression on the injured muscular fibers which in turn helps in the healing process. Strongly indicated for use during sport. Made with our exclusive AIRFLEX fabric. 100% cotton on the skin; it is breathable, hypo allergenic and neoprene free. FDA UDI
- Model / Reference
- 80 R FDA UDI
- Description
- The M-Brace #80 Thigh Wrap insures a constant pressure on the quadriceps and the hamstrings following muscle strains to alleviate pain and to shorten the healing process. Different materials were used in its construction among which two in particular; 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. The wrap can be perfectly adjusted. It comes with an inside pad that can be positioned in the exact place of injury. To ensure maximum comfort especially during extended use, this product was made with a breathable fabric. INDICATIONS Indicated for muscles strains (quad or femoral bicep). Alleviates pain by exerting a constant compression on the injured muscular fibers which in turn helps in the healing process. Strongly indicated for use during sport. Made with our exclusive AIRFLEX fabric. 100% cotton on the skin; it is breathable, hypo allergenic and neoprene free. FDA UDI
Identifiers
- Catalog Number
- 80 FDA UDI
- Primary DI / UDI-DI
- 05391512280239 FDA UDI
- FDA Product Code
- MHW FDA UDI
- GMDN Term
- Compression/pressure tubular garment 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: Compression/pressure tubular garment
M-Brace Air by Indaco Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Compression/pressure tubular garment.
- SOLIDEA — CALZIFICIO PINELLI SRL · Class I
- Vive — VIVE HEALTH LLC · Class I
- SOLIDEA — CALZIFICIO PINELLI SRL · Class I
- Optiform Flex — SIGVARIS, INC. · Class I
- SOLIDEA — CALZIFICIO PINELLI SRL · Class I
- SOLIDEA — CALZIFICIO PINELLI SRL · Class I
- SOLIDEA — CALZIFICIO PINELLI SRL · Class I
- Vive — VIVE HEALTH LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Indaco Srl
Sources (1)
- FDA UDI 414f273d-169c-425f-93dd-080a58f8fbc5 35 fields · synced Jun 1, 2026