Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))

The Upper Arm Electronic Blood Pressure Monitor (U87Y, U86E, U81X, and U83Z series) is designed to measure systolic and diastolic blood pressure and pulse rate in adults aged 12 and older using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm). The device can be used in medical facilities or at home and is not intended to be diagnostic.

The device uses an automatic internal pump and oscillometric method to measure blood pressure. It is powered by four AA or AAA batteries or an AC adapter. The cuff accommodates arm circumferences of 220-420 mm, which is larger than the predicate device (220-360 mm). Measuring range is 0-299 mmHg with accuracy of ±3 mmHg for pressure and ±5% for pulse. The device includes an irregular heartbeat prompt function, which was not publicly available in the predicate.

IEC 60601-1 (General requirements for medical electrical equipment), IEC 60601-1-2 (Electromagnetic compatibility), IEC 80601-2-30 (Automated non-invasive sphygmomanometers), IEC 60601-1-11 (Home healthcare environment), ISO 10993-1 (Biocompatibility), and ISO 81060-2:2018 (Clinical validation of automated blood pressure measurement).

The subject device is substantially equivalent because it uses the same oscillometric working principle, serves the same intended patient population (adults over 12), targets the same anatomical site (upper arm), and achieves identical measuring accuracy (±3 mmHg for pressure, ±5% for pulse) as the predicate device. The differences—larger cuff size (220-420 mm vs. 220-360 mm), support for AAA batteries, expanded operating environment range, and addition of an irregular heartbeat prompt—do not raise safety or effectiveness issues because the device was validated against IEC 80601-2-30 and ISO 81060-2 standards, clinical testing showed no adverse events across 92 subjects including hypertensive patients, and the expanded specifications do not compromise core performance.