Electronic Blood Pressure Monitor

The Electronic Blood Pressure Monitor (models D6606US, D6607US) is a noninvasive upper-arm blood pressure measurement device intended to measure systolic and diastolic blood pressure and pulse rate in populations over 12 years old in household or medical settings. It uses an automatic inflatable cuff and oscillometric measurement method, with automatic inflation and pressure release, displaying results on a backlit LCD screen with memory storage for two users at up to 99 measurements each.

The subject device uses the same oscillometric measurement principle, automatic electronic pump inflation, automatic pressure release valve deflation, and semiconductor pressure sensor as the predicate. Minor differences include: memory capacity (two users, 2×99 groups vs. 180 groups), display content (adds user icons, irregular pulse icon, and voice on/off control), cuff fabric material (210D raw silk cloth vs. 420D polyester), smaller dimensions (116×110×50mm vs. 141×106×70mm), and lighter weight (278g vs. 323g without battery). All components, performance ranges, and measurement accuracy remain identical.

ISO 81060-2 (clinical investigation of automated noninvasive sphygmomanometers), IEC 80601-2-30:2018 (particular requirements for automated noninvasive sphygmomanometers), IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-6 (usability), IEC 60601-1-11 (home use), ISO 10993-5 (cytotoxicity testing), and ISO 10993-10 (skin sensitization and irritation testing).

The subject device is substantially equivalent because it shares the same indication for use, measurement method (oscillometric), critical design components (pump, sensor, cuff interface), and measurement algorithm as the predicate device HTD6602US (K223170). The five identified differences—memory capacity, display features, cuff fabric, dimensions, and weight—do not raise new safety or effectiveness questions: the cuff fabric change was validated through biocompatibility testing per ISO 10993-5 and 10993-10 with positive results; display enhancements align with IEC 80601-2-30:2018 requirements; and physical differences have no functional impact. Since the subject device meets identical performance specifications and international standards, and clinical study results can be transferred from the predicate, repeated clinical testing is not warranted.