510(k) K062873

SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS by E.C.I. USA Corporation — Product Code DWL

K062873 is an FDA 510(k) premarket notification submitted by E.C.I. USA Corporation for the device "SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS". The FDA issued a decision of Substantially Equivalent on March 20, 2007. The device falls under product code DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)), a Class II device regulated under 21 CFR 880.5780.