Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)

The Arm Blood Pressure Monitor (models MJ1L, MJ2L, RN3L, RN4L, RN5L) is an automatic, noninvasive blood pressure monitoring device that measures systolic and diastolic blood pressure and pulse rate using the oscillometric method. It is intended for use in hospitals, families, schools, and medical centers for adult patients and is not suitable for neonates or pregnancy.

The subject device uses an inflatable cuff applied to the upper arm with automatic air pump inflation and solenoid valve deflation. It features an LCD digital display, stores 2×60 sets of measurement data, operates at 10–40°C with Li-ion rechargeable battery power (3.7V 800mA), and achieves blood pressure accuracy of ±3 mmHg with a measurement range of 0–294 mmHg and pulse rate range of 50–100 bpm.

IEC 60601-1:2020 (general safety), IEC 60601-1-2:2020 (EMC), IEC 60601-1-11:2020 (home healthcare), IEC 80601-2-30:2018 (automated sphygmomanometers), IEC 62133-2:2017 (lithium battery safety), ISO 81060-2:2018+A1:2020 (clinical validation of automated blood pressure measurement), and ISO 10993-1 (biocompatibility).

The subject device is substantially equivalent to the predicate device (Electronic Blood Pressure Monitor YE620D, K200939) because both use the same oscillometric measurement principle, target the same adult population, and achieve identical blood pressure accuracy (±3 mmHg) and pulse accuracy (±5% of reading). Minor differences in blood pressure range, pulse rate range, deflation mechanism, operating conditions, and power source do not raise new safety or effectiveness questions, as confirmed by performance testing and clinical validation.