Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)

The Arm Blood Pressure Monitor (models ARM-30H, ARM-30J, ARM-30K, and ARM-90B) is an automatic, non-invasive blood pressure monitor that measures systolic and diastolic blood pressure and pulse rate using oscillometric technique. It is intended for use in medical facilities and home settings to measure blood pressure in adults via an inflatable cuff wrapped around the upper arm.

The proposed devices use oscillometric measurement principle with a blood pressure range of 30-255 mmHg (±3 mmHg accuracy) and pulse measurement range of 40-199 bpm (±5% accuracy). Models ARM-30H, ARM-30J, and ARM-30K use no wireless transmission, while ARM-90B includes 4G network capability. All models use a 22-42 cm cuff size and operate at 5°C-40°C with similar environmental specifications to the predicate. Battery types differ: proposed devices use lithium-ion 3.7V versus the predicate's 4×1.5V AA batteries.

Testing standards include IEC 60601-1 (general electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare environment), IEC 80601-2-30 (automated non-invasive sphygmomanometers), ISO 10993-1/5/10/23 (biocompatibility), ANSI C63.27:2017 (wireless coexistence), AAMI TIR69:2017 (RF wireless risk management), and ISO 81060-2:2018 (clinical investigation of automated blood pressure measurement).

Substantial equivalence is supported by identical intended use, measurement principle, and performance specifications (same blood pressure range, accuracy, heart rate range, cuff size, and display features). Clinical validation studies on ARM-30H and ARM-90B per ISO 81060-2 demonstrated that mean error and standard deviation met the standard's limits with no adverse effects. The devices share the same manufacturer, application scenario, patient population (adults), and biocompatibility evaluation approach as the predicate, with only minor differences in battery technology and wireless capability that do not affect core measurement performance.