Coretech Compression System (Coretech RHB3003)

The Coretech Compression System RHB3003 is a pneumatic sequential compression device that treats lymphedema, venous stasis ulcers, venous insufficiency, and peripheral edema by inflating and deflating air chambers in a garment to move excess fluid from impaired lymphatic regions to healthy areas. It is safe for both home and hospital use and is prescribed by healthcare providers.

The device features a smaller but heavier plastic controller with LED touch controls compared to the predicate CircuFlow 5150's push-button interface. It includes both sequential gradient pressure and peristaltic compression modes, operates at 20–80 mmHg pressure, has an 82-second cycle time with 15-second dwell time, supports 4 or 8 chamber garments (versus predicate's 8 chambers), and accepts 30/45/60-minute treatment durations. Electrical requirements are 100–127V/220–240V at 50/60 Hz.

IEC 60601-1 (medical electrical equipment general safety), IEC 60601-1-11 (home healthcare environment), IEC 60601-1-6 (usability), and IEC 62304 (medical device software lifecycle processes). Mechanical bench testing covered inflation/deflation performance, pressure calibration accuracy, cycle time verification, garment integrity, and burst pressure.

The Coretech RHB3003 operates on identical fundamental technology, mode of action, and sequential distal-to-proximal inflation principles as the predicate CircuFlow 5150. Although it differs in controller size/weight, user interface (LED touch vs. push-button), pressure modes (adds peristaltic), dwell time, and chamber count, these differences do not raise new safety or effectiveness questions because the device performs equivalent mechanical functions at comparable pressures within the same treatment envelope. Comprehensive testing of electrical safety, software validation, and mechanical performance demonstrates equivalent safety and effectiveness profiles.