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ManaGO71 Ankle Brace Medium

Manamed, Inc. · Model MGO71M · UDI-DI 00810113683348

ITW

510(k) clearances

Adverse events

Recalls

462

Facilities

Description

The ManaGO 71 provides three different levels of support in one brace. The unique design allows components to be removed as the patient's condition improves. In its extended gauntlet configuration, the ManaGO 71 provides maximum protection for ankle sprains and Syndesmosis injuries. The gauntlet and hinge stirrup with footplate captures the entire ankle mechanism. Removable upper cuff and hinge stirrup with footplate can be removed as recovery improves. Features: Speed lacing ankle foot brace that extends to boot height on the calf Interlocking plastic plates and hinge assembly Figure-eight strapping

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.