Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo

The Wrist Blood Pressure Monitor is a battery-powered automatic device that measures systolic and diastolic blood pressure and pulse rate in adults using non-invasive oscillometric technique. It consists of an inflatable cuff wrapped around the wrist and displays results in mmHg or kPa, for use in medical facilities or at home.

The device uses oscillometric measurement principle with a blood pressure range of 0-295 mmHg (±3 mmHg accuracy) and pulse rate range of 40-199 bpm (±5% accuracy). It features a wrist cuff size of 13.5-19.5 cm, LCD or LED display, auto-shutdown, and operates at 5°C–40°C with 15%-90% humidity. Power sources vary across 13 models: some use AAA batteries, some include AC/DC adapters, and others use lithium-ion batteries.

IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare), ISO 80601-2-30 (automated sphygmomanometers), ISO 10993-1/5/10 (biocompatibility), and ISO 81060-2:2018-11 (clinical validation of non-invasive blood pressure measurement).

The subject devices are substantially equivalent because all 13 models share identical intended use, oscillometric measurement principle, core blood pressure algorithm, and cuff size with the predicate device (K213503). Despite variations in appearance, weight, dimensions, and power source options across models, these differences do not affect safety or effectiveness and comply with all applicable IEC/ISO standards. Clinical testing of three device groups (300 total subjects) demonstrated that mean error and standard deviation of systolic/diastolic pressure measurements met ISO 81060-2 limits with no adverse effects, confirming equivalent performance to the predicate.