PnueAira (PNCU-01)

The PnueAira (PNCU-01) is a pneumatic compression device designed for at-home treatment of lower extremity lymphedema and related conditions. It uses air to systematically compress a patient's limbs through garments (core or full-leg) connected to a control unit, supporting both peristaltic and sequential compression modes to increase lymphatic flow and reduce swelling.

The PnueAira features a control unit with mechanical rotary knobs and buttons, supports up to 32 pressure chambers depending on garment size, delivers 0–80 mmHg (core limited to 50 mmHg) with ±5 mmHg accuracy, offers treatment times of 30, 34, 60, and 90 minutes, and operates on 100–240 VAC, 50/60 Hz. Compared to the primary predicate (AIROS 6P), it has more chambers (up to 32 vs. 12), expanded treatment durations, and mechanical rather than tactile button interfaces, though both use pressure-based control in plastic enclosures.

Electrical safety (IEC 60601-1:2005/AMD2:2020), usability (IEC 60601-6:2010/AMD2:2020), home use (IEC 60601-1-11:2015/AMD1:2020), EMC (IEC 60601-1-2:2014/AMD1:2020), FCC Part 15 Subpart B, ISO 14971:2019 risk management, ISO 10993-1:2018 biocompatibility (cytotoxicity, sensitization, irritation), ASTM D4169 shipping, and IEC 62304:2006+A1:2015 firmware testing.

The PnueAira is substantially equivalent because it shares the same indications for use as the AIROS 6P predicate (lymphedema, venous insufficiency, post-mastectomy edema, wound healing), employs identical technological architecture (electronic controller with firmware managing pneumatic pressure chambers in garments), uses comparable materials and operation methods, and raises no new safety or effectiveness concerns. The minor design differences (more chambers, mechanical interface, expanded treatment times) do not create different risks or questions about safety and effectiveness—they represent incremental feature enhancements within the established pneumatic compression device category.