Cryopush Cold Compression Device (A02-P-001)

The Cryopush Cold Compression Device is a portable, battery-powered compression and cold therapy system consisting of a main unit and interchangeable wraps. It delivers selectable pressure levels (20–100 mmHg) in cycles of 10-second compression followed by 20-second decompression, with an integrated cold pack that operates at −18°C to +2°C. It is indicated for temporary relief of minor muscle aches and pains, temporary increase in circulation, and localized cold therapy in people in good health.

The device shares the same regulation (21 CFR 890.5650), classification (Class II), product codes (IRP, IME), intended use, pressure range (0–100 mmHg), and operating environment as the predicate device K222669. Key differences include expanded treatment areas (hips, arms, back, neck in addition to lower limbs), multiple wrap sizes, and a slightly wider cold pack operating temperature range (−18°C to +2°C vs. −18°C to −4°C); these differences do not raise new safety or effectiveness concerns.

IEC 60601-1:2005 (medical electrical equipment general safety), IEC 60601-1-11:2015 (home healthcare), IEC 60601-1-2:2014 (electromagnetic compatibility), IEC 62133-2:2017 (lithium battery safety), AIM 7351731 Rev. 3.00 (RF immunity), and IEEE ANSI C63.18-2014 (RF emissions immunity). Software validation followed FDA Guidance for Industry on Device Software Functions (June 2023).