Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)

The Blood Pressure Monitor (18 models: RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298) is an automated, battery-powered device that measures systolic and diastolic blood pressure and pulse rate using non-invasive oscillometric technique. It is intended for use in medical facilities or at home on adult patients.

The subject device differs from the predicate (AOJ-30B) in four areas: (1) blood pressure measurement range of 25–255 mmHg versus 30–255 mmHg; (2) cuff circumference of 22–32 cm versus 22–36 cm; (3) power supply using USB 5V or 6V DC with AAA batteries versus 6V DC with AAA batteries only; and (4) slightly narrower arm circumference range. All devices maintain ±3 mmHg accuracy and the same measurement principles and components.

ISO 10993-1, ISO 10993-5, ISO 10993-10 (biocompatibility); IEC 60601-1 and IEC 60601-1-11 (electrical safety); IEC 60601-1-2 (EMC); IEC 80601-2-30 (automated sphygmomanometers); IEC 60601-1-6 (usability); ISO 81060-2:2018 (clinical validation of automated blood pressure monitors).

The subject device shares the same design principle, components (LCD, cuff, MCU, pump, batteries), measurement method, accuracy specifications, and intended use as the predicate device. The differences in measurement range, cuff circumference, and power supply are minor and do not raise safety or effectiveness concerns because: the narrower measurement range (25–255 vs. 30–255 mmHg) is verified to IEC 80601-2-30; the cuff circumference difference is slight and both cover typical arm sizes; and power supply modifications are justified by IEC 60601-1 testing. Clinical testing on 100 subjects per ISO 81060-2:2018 showed no adverse effects and mean error within acceptable limits.