510(k) K012601

CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH by Clearmedical, Inc. — Product Code JOW

K012601 is an FDA 510(k) premarket notification submitted by Clearmedical, Inc. for the device "CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH". 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.