Home › INDACO SRL › M-Brace Air

M-Brace Air

INDACO SRL · Model 80 R · UDI-DI 05391512280239

MHW

510(k) clearances

Adverse events (5 deaths)

Recalls

238

Facilities

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.

Recalls

Date	Firm	Reason
2026-09-02	Safeguard US Operating LLC	Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of s
2016-02-24	Amd Ritmed	Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
2006-08-16	International Medsurg Connection, Inc.	The bandages labeled as sterile had not been sterilized prior to distribution.
2006-08-16	International Medsurg Connection, Inc.	The bandages labeled as sterile had not been sterilized prior to distribution.
2006-08-16	International Medsurg Connection, Inc.	The bandages labeled as sterile had not been sterilized prior to distribution.
2006-08-16	International Medsurg Connection, Inc.	The bandages labeled as sterile had not been sterilized prior to distribution.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.