510(k) K012614

KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN by Medical Instruments Technology, Inc. — Product Code JOW

K012614 is an FDA 510(k) premarket notification submitted by Medical Instruments Technology, Inc. for the device "KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN". The FDA issued a decision of Substantially Equivalent on May 1, 2002. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Medical Instruments Technology, Inc. has at least 4 other 510(k) clearances on record.