Bio Arterial Deluxe (IC-BAP-DX)

The Bio Arterial Deluxe (IC-BAP-DX) is a pneumatic compression device consisting of an inflatable sleeve (garment) connected to a pump that cyclically compresses the limbs to stimulate blood flow. It is intended to improve circulation in the upper and lower extremities, treat intermittent claudication, rest pain, diabetic foot, and other ischemic conditions, and serve as adjunct therapy for lower extremity ischemic disease.

The subject device uses the same operating principle, disc valve assembly, cycle time (20 seconds), pressure range (20-150 mmHg), and pressure accuracy (±20%) as the predicate. It operates at 120 VAC, 60 Hz (versus predicate's 100-240V, 50/60 Hz), has identical electrical classification (Class II), applied part type (BF), and ingress protection (IP21). The subject device is smaller and lighter (3.3 lbs vs. 7.5 lbs) and adds an arm garment in addition to predicate garments.

Electrical safety and electromagnetic compatibility per ANSI/AAMI ES60601-1:2005/(R)2012, IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-1-6:2010, and IEC 60601-1-11:2015 (with subsequent amendments). Software classified as Safety Class A per IEC 62304.

The subject device is substantially equivalent because it has identical operating principles, core components, and performance specifications as the legally marketed predicate (K131327). The minor differences—smaller size, lower power rating, and addition of an arm garment (which matches cleared devices K024019)—do not raise different safety or effectiveness questions, and the device uses the same garments and disc valve assembly.