SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS

SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS is an FDA 510(k)-cleared medical device (K062873) manufactured by E.C.I. USA Corporation. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 19, 2007. Regulation: 8.