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TM "Soloventex" 120-142 XXL

REABILITIMED TOV · Model 120-142 XXL · UDI-DI 04823097716366

FQL

510(k) clearances

Adverse events

Recalls

273

Facilities

Description

Women's open-toe socks, 2nd compression class 23-32 mm. Hg., beige color, transparent structure, made of elastane and polyamide threads. The compression effect of the knitwear causes the following therapeutic effects: narrows the lumen of the veins, increases the rate of venous blood outflow, prevents its stagnation, normalizes the activity of the muscular-venous pump; prevents the formation of blood clots; protects the legs from swelling, fatigue and pain.

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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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.