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TM "Rehabilitimed" GS-2 XL Comfort
REABILITIMED TOV · Model GS-2 XL Comfort · UDI-DI 04823097716892
1
510(k) clearances
70
Adverse events
3
Recalls
459
Facilities
Description
It is a fabric shoe, without a toe and heel, made of a multilayer material with a high cotton content. Reinforced on the sides with four metal stiffening ribs, curved to the shape of the leg and covered with a special material for a comfortable fit of the orthosis to the bone protrusions of the joint. The orthosis is attached to the leg by textile fasteners, which allow you to adjust the pressure on the fabric and position the product on the leg with maximum comfort. Graphite color.
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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Get your free API keyRead the docsData 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.