Compression Therapy Device (LGT-2210DS)

The Compression Therapy Device (LGT-2210DS) is an intermittent pneumatic compression system comprising a controller unit, multi-chamber inflatable sleeves, and hoses. It sequentially inflates and deflates chambers to apply circulating pressure on limbs, promoting blood circulation and lymphatic drainage. The device is intended for prophylaxis and treatment of edema including chronic venous edema, lymphedema, and post-mastectomy lymphedema, for use only by qualified medical professionals in clinical and hospital settings with patients over 22 years old.

The device uses a compressor and valve system with sequential chamber inflation, offering treatment times of 1–120 minutes (default 30 min) at pressure ranges of 7.5–187 mmHg. It features both 4-chamber and 6-chamber sleeve options with 10 programmable treatment modes, some with gradient pressure capability. The unit is microprocessor-controlled, AC-powered (100–120V, 60 Hz), weighs 10 kg, and has a 10-year service life; reusable sleeves rated for 30,000 cycles and main components for 5 years.

IEC 60601-1:2012 (electrical safety), IEC 60601-1-2:2014 (EMC), IEC 60601-1-6:2010 (usability). Biocompatibility tested per ISO 10993-10:2021 (skin sensitization), ISO 10993-5:2009 (in vitro cytotoxicity), and ISO 10993-23:2021 (irritation). Reliability and performance testing was conducted including service-life evaluation.

The subject device and predicate (MK300L, K112441) share identical product codes (IRP), regulation numbers (21 CFR 890.5650), and Class II designation. Both employ compressor-valve systems with sequential chamber inflation for the same therapeutic indications. Differences in treatment time range (1–120 min vs. 1–90 min), pressure ranges (7.5–187 mmHg vs. 10–200 mmHg), and treatment modes are non-significant because the subject's pressure range is narrower and contained within the predicate's range, treatment time defaults to 30 minutes for standard use, and mode variations differ only in chamber inflation sequence while maintaining lower pressures. Size, weight, and power specifications variations comply with IEC 60601-1 and do not raise new safety or effectiveness concerns.