Venera 608 Deep Vein Thrombosis (DVT) Prevention System

The Venera 608 is a pneumatic compression device that prevents deep vein thrombosis by periodically inflating soft compression sleeves around the limb. It delivers a 60-second cycle with approximately 12 seconds of inflation at 40 mmHg (calf/thigh) or 120 mmHg (foot) followed by 48 seconds of relaxation to enhance venous circulation and prevent blood clotting.

Both subject and predicate devices use identical system architecture (pump, tubing, cuffs) and operate at the same pressures and cycle times. The Venera 608 differs in using different cuff materials from the same plastic/fabric family and features an optimized user interface with more sophisticated control buttons and display functions compared to the predicate's limited screen capabilities.

Electrical safety and EMC: IEC 60601-1:2005, IEC 60601-1-2:2014+A1:2020, IEC 60601-1-6:2010. Biocompatibility: ISO 10993-5:2009, ISO 10993-23:2021, ISO 10993-10:2021. Functional testing included pressure accuracy, cycle time, alarm function, cuff burst and leak testing, and software verification/validation.

The Venera 608 operates on the identical pneumatic compression principle as the predicate (Cirona 6200) with matching physical components, form factors, operating pressures, and therapy cycle parameters. Although materials and user interface differ, these are non-functional variations that do not alter the fundamental mechanism of limb compression for DVT prevention. No new safety or effectiveness concerns are raised by these differences, making the devices substantially equivalent in intended use and technology.