Compression Therapy Device (LGT-2202DVT)

The Compression Therapy Device (LGT-2202DVT) is an intermittent pneumatic compression system consisting of a controller, sleeves, and hoses that sequentially inflate and deflate to apply pressure on limbs and promote blood circulation. It is indicated for deep vein thrombosis and pulmonary embolism prophylaxis (leg compression), and for circulation enhancement, edema management, extremity pain relief, leg ulcers, and venous insufficiency (foot compression) in patients over 22 years old.

The device features 4 compression modes (M1-M4), set pressures of 45/40/30 mmHg for calf/thigh and 130 mmHg for foot, continuous timer operation, AC100-240V 50/60Hz power with lithium battery backup (11.1V, 3500mAh, 9-hour runtime), Class I Type B Applied Part electrical protection, and IPX0 water ingress protection. It differs from the predicate (K120944) in compression modes (4 vs 3), battery capacity, and some dimensional/weight specifications, but maintains identical indications, product code, and fundamental operating principles.

Testing was performed per IEC 60601-1:2012 (medical electrical equipment general safety), IEC 60601-1-2:2014 (electromagnetic compatibility), IEC 60601-1-6:2010 (usability), ISO 10993-10:2021 (skin irritation/sensitization), ISO 10993-5:2009 (in vitro cytotoxicity), and ISO 10993-23:2021 (irritation testing). Service life validation confirmed 10-year controller life, 5000 uses for sleeves, and 5-year component life.