Globalcare Blood Pressure Monitor (GUS610)

The Globalcare GUS610 is an automatic upper arm blood pressure monitor for home use that measures systolic and diastolic blood pressures and pulse rate in adults. The device is powered by batteries or a mains adapter and displays results on an electronic screen, with clinical outputs including blood pressure readings, pulse rate, cardiac arrhythmia detection, risk level, and hemodynamic rest condition indication.

The only technological difference from the predicate device is the addition of an optional larger upper arm cuff with a maximum circumference of 52 cm (compared to 42 cm in the predicate). The new cuff is manufactured from the same gray Polyester 200D material as the predicate device's cuff.

ISO 81060-2:2018 (Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type) and IEC 80601-2-30 (medical device safety standard for blood pressure monitors).

The subject device meets substantial equivalence because the only change is the availability of an optional larger cuff accessory with the same material and manufacturing as the predicate. Clinical testing with 87 subjects (259 datasets) using the larger cuff demonstrated that blood pressure and pulse rate measurements met ISO 81060-2:2018 criteria for both mean difference/standard deviation and the manufacturer's accuracy specifications. Third-party testing confirmed continued compliance with IEC 80601-2-30 when the device is used with the new cuff, with no adverse incidents or failed measurements.