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TM "Rehabilitimed" DS-1 UNI Comfort

REABILITIMED TOV · Model DS-1 UNI Comfort · UDI-DI 04823097716847

ITW
1
510(k) clearances
70
Adverse events
3
Recalls
458
Facilities

Description

It has the appearance of an open structure in the form of a boot, to which a transverse crossbar is attached, which prevents rotation of the foot and the entire leg to the right, left, and additional fixing straps keep the foot from bending movements up and down. Beige color.

Recalls

DateFirmReason
2016-02-24Ossur H / FOssur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound
2016-02-24Ossur H / FOssur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound
2015-04-13United Surgical AssociatesThe 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.