Wrist Blood Pressure Monitor (BPM-W1VL)

The Wrist Blood Pressure Monitor (BPM-W1VL) is a noninvasive oscillometric blood pressure measurement device intended to measure systolic and diastolic blood pressure and pulse rate in persons older than 12 years in medical facilities or at home. It uses an inflatable cuff around the wrist with a circumference range of 13.5–21.5 cm.

The device uses oscillometric measurement, automatic electric pump inflation, automatic rapid deflation valve, piezo resistance pressure sensor, and LCD digital display. It stores up to 99 groups of measurements, measures systolic 60–230 mmHg and diastolic 40–130 mmHg with ±3 mmHg accuracy, and pulse 40–200 beats/min with ±5% accuracy. It operates on 2 AAA batteries.

ISO 81060-2 (Third edition 2018-11 Amendment 1 2020-01) for clinical accuracy; IEC 80601-2-30 and IEC 60601-1-2 for performance and EMC; ANSI AAMI ES60601-1 and IEC 60601-1-11 for electrical safety; ISO 10993-1 for biocompatibility; and IEC 62304 for software verification.

The BPM-W1VL is substantially equivalent to the predicate device HWA10 (K231310) because both use the same oscillometric measurement principle, same product code (DXN), same regulatory classification (Class II), and similar technological characteristics including wrist circumference range and measurement accuracy. Differences in patient population, memory size, measurement ranges, and dimensions do not raise new safety or effectiveness questions, as demonstrated by bench testing and clinical accuracy testing per ISO 81060-2.