Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);

The Arm Blood Pressure Monitor is an automatic, battery-powered device that measures systolic and diastolic blood pressure and pulse rate using the oscillometric technique. An inflatable cuff wraps around the upper arm, and the device displays results in mmHg or kPa. It includes data storage, low battery indication, and auto-shutdown features. It is intended for use in medical facilities or at home for adult patients.

The device uses oscillometric measurement with ±3 mmHg accuracy and ±5% pulse rate accuracy. It measures on the upper arm with cuff sizes 22–42 cm and pulse range 40–199 bpm. Operating temperature is 5–40°C with 15–90% humidity. Some models use AAA batteries while others use AA batteries (minor difference from predicate). Display includes systolic/diastolic pressures, pulse rate, date, time, WHO BP classification, and memory records. All 28 models share the same measurement principle, core algorithm, and similar design with variations only in appearance, dimensions, and non-critical functions.

IEC 60601-1 (general electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-11 (home healthcare environment), IEC 80601-2-30 (automated non-invasive sphygmomanometers), ISO 10993-1/5/10/23 (biocompatibility), and ISO 81060-2:2018-11 with Amendment 1:2020 (clinical accuracy for automated blood pressure measurement).

The proposed device is substantially equivalent to the predicate (AOJ models, K222125) because it maintains identical intended use, measurement principle, accuracy specifications (±3 mmHg), patient population (adults), measurement site (upper arm), and operational/storage environments. Clinical testing of 28 models divided into 7 groups (total ≥92 subjects per group, gender/age balanced) demonstrated that mean error and standard deviation met ISO 81060-2 limits with no adverse effects. Minor physical differences (dimensions, weight, battery type) do not affect safety or effectiveness and were verified by testing. The subject device removes the Bluetooth wireless function present in some predicate models, making it functionally more conservative.