510(k) K213533

Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL by Bio Compression Systems, Inc. — Product Code IRP

K213533 is an FDA 510(k) premarket notification submitted by Bio Compression Systems, Inc. for the device "Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL". The FDA issued a decision of Substantially Equivalent on February 16, 2022. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Bio Compression Systems, Inc. has at least 10 other 510(k) clearances on record.