Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL)

This is an intermittent pressure compression system (Compression Pump PT1005A with leg compression cuffs in sizes S–XXXL) intended to temporarily relieve minor muscle aches and pains and temporarily increase circulation in healthy people. It uses sequential inflation of air-filled chambers to simulate manual massage.

The device operates at 20–200 mmHg pressure with six selectable modes, a 30-second cycle time, and treatment duration of 0–30 minutes (selectable as 10, 20, or 30 min). It has 4 chambers, weighs 1.6 kg, and draws 30 W. Key difference from predicate: AC-powered (100–240 V) rather than battery-powered; lower pressure range and shorter therapy times than predicate.

IEC 60601-1 (general medical electrical equipment safety), IEC 60601-1-2 (electromagnetic compatibility), and IEC 60601-1-11 (home healthcare environments).

The subject device and predicate (K243320, VU-IPC04B) share identical intended use, mechanism (sequential chamber inflation), treatment area (legs), and OTC regulatory pathway. Although the subject device differs in power source, pressure range (lower), therapy duration (shorter), chamber count (4 vs 6), and physical dimensions, these differences do not raise safety or efficacy concerns. Lower pressure and shorter treatment times actually enhance safety, and performance testing demonstrated the subject device meets the same safety standards. The treatment area and usage instructions fall within the same range as the predicate.