Hot and Cold Compression System (A02-C-032)

The Hot and Cold Compression System (A02-C-032) is an AC-powered device that delivers iceless cold therapy, heat therapy, and intermittent pneumatic compression to treat post-surgical and acute injuries to reduce edema, swelling, and pain. It is intended for use by licensed healthcare professionals in rehabilitation facilities, outpatient clinics, and athletic training settings, treating one patient at a time with compatible water-circulating cuffs.

The device features a single fluid reservoir (550 mL capacity) with thermoelectric cooling and heating mechanisms, an LED touch-button interface, heat range of 38–45°C, cold range of 4–16°C, compression range of 15–75 mmHg, adjustable treatment times, and various anatomical single-patient-use nylon cuffs. It is lighter and more compact than the primary predicate (16.5 kg vs. 78 kg) due to a unified reservoir design.

IEC 60601-1 (medical electrical equipment general requirements), IEC 60601-1-2 (electromagnetic compatibility), ISO 10993-1/5/10 (biocompatibility), software verification and validation per Basic Documentation Level, seam strength testing, temperature control accuracy, pressure control accuracy, and skin temperature studies on human subjects.

The device combines cold, heat, and compression therapies with the same intended use and indications as the predicate devices (Med4 Elite K171685 and Therm-X K193550). Minor differences in treatment time ranges, temperature set points, user interface design, and cuff materials do not raise new safety or effectiveness issues; clinical skin temperature testing confirmed no thermal damage, and all performance specifications meet predetermined limits equivalent to predicate devices.