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M-Brace Air

INDACO SRL · Model 17 S · UDI-DI 05391512280185

ITW Prescription

510(k) clearances

Adverse events

Recalls

462

Facilities

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.

Recalls

Date	Firm	Reason
2016-02-24	Ossur H / F	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound
2016-02-24	Ossur H / F	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound
2015-04-13	United Surgical Associates	The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

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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.