860 Select Comfort
SIGVARIS INC · Model 862P · UDI-DI 00745129200770
Description
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-10-07 | Surgical Appliance Industries | During an audit with the FDA, it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained |
| 2011-10-07 | Surgical Appliance Industries | During an audit with the FDA, it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained |
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