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M-Brace Air

INDACO SRL · Model 134 LE · UDI-DI 05391512282011

ILH Prescription

510(k) clearances

Adverse events

Recalls

427

Facilities

Description

This Wrist Splint has been designed and produced as a support and protective device for muscular damages, as well as for tendon and joint injuries either caused by trauma, stress or excessive fatigue. Available in right or left for a perfect fit and superior comfort. For the development of this device, two special fabrics have been matched: • The inside fabric is made from a soft breathable microfiber, extremely comfortable to the skin. • The fabric on the outside, made with a particular and dense nylon mesh forming microscopic and resistant loops, allows the Velcro to securely fasten on the surface. Due to this specific construction, a vast range of closing positions are available, depending on the tension desired. The two aluminum stays, pre-shaped and moldable for custom fitting, can be removed according to the need of immobilization of the patient.

Recalls

Date	Firm	Reason
2023-08-18	North Coast Medical Inc	The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.

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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.