Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)

The Arm Blood Pressure Monitor (models HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) is an automatic, non-invasive device that measures systolic and diastolic blood pressure as well as pulse rate in adults using oscillometric technique. It is intended for use in medical facilities or at home, with features including data storage, low battery indication, and display in mmHg or kPa units.

Minor differences from the predicate device include: wider blood pressure measurement range (0-260 mmHg vs. 25-255 mmHg), larger cuff circumference range (22-36 cm vs. 22-32 cm), slightly broader operating humidity tolerance (15-90% vs. 15-80%), different power supply options (AAA batteries or AC adapter, versus predicate's 6V batteries), and updated biocompatibility testing standards (ISO 10993-23 added). Accuracy (±3 mmHg) and core functionality remain identical.

IEC 60601-1 (electrical safety), IEC 60601-1-11 (home healthcare environment), IEC 60601-1-2 (electromagnetic compatibility), IEC 80601-2-30 (automated sphygmomanometer performance), ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23 (biocompatibility), and ISO 81060-2:2018 (clinical validation of non-invasive sphygmomanometers).

The subject device is substantially equivalent to the predicate device because both share the same intended use, oscillometric measurement principle, target population (adults), and application site (upper arm). The technological differences (measurement range, cuff size, power supply, environmental specs) are minor and do not raise different safety or effectiveness questions, as demonstrated by compliance with relevant international standards and clinical testing showing no adverse effects in 85 subjects.