510(k) K012616

CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR by Clearmedical, Inc. — Product Code JOW

K012616 is an FDA 510(k) premarket notification submitted by Clearmedical, Inc. for the device "CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR". The FDA issued a decision of Substantially Equivalent on February 6, 2002. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Clearmedical, Inc. has at least 10 other 510(k) clearances on record.