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TM "Rehabilitimed" GS-2 XL Comfort
REABILITIMED TOV · Model GS-2 XL Comfort · UDI-DI 04823097722640
1
510(k) clearances
76
Adverse events
3
Recalls
458
Facilities
Description
The graphite-colored ankle-foot orthosis provides external semi-rigid fixation. The detachable orthosis is reinforced on the sides with four metal stiffening ribs, curved according to anatomical shapes and covered with a special material for a comfortable fit to the bone protrusions of the joint. Convenient fastening on the leg is carried out due to textile fasteners. Made of multilayer material with a cotton layer to the body and polyamide on the outside.
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.