Wrist Blood Pressure Monitor (OHMS11, OHMS12)

The Wrist Blood Pressure Monitor (OHMS11, OHMS12) is a reusable, home-use device that measures blood pressure noninvasively in adults with wrist circumference from 13.0 to 21.0 cm. It uses the oscillometric method with an integral pump for cuff inflation and electric valve for deflation, powered by a rechargeable lithium-polymer battery, with results displayed on an integrated screen.

The subject device matches the predicate (K182481) in measurement range, accuracy, pressure sensor, measurement method, inflation/deflation methods, and intended use population. Minor differences include cuff range (13.0-21.0 cm vs predicate's range), display screen material (similar effect but different material), power supply, operating/storage conditions, and physical dimensions/weight—none considered essential parameters affecting effectiveness or safety.

IEC 60601-1:2020 and IEC 60601-1-2:2020 for electrical safety and electromagnetic compatibility; IEC 80601-2-30 for blood pressure device safety; ISO 81060-2:2019 for clinical validation of automated blood pressure measurement; ISO 10993-1 for biocompatibility testing (cytotoxicity, sensitization, irritation).

The subject device has all essential features of the predicate device. Although the cuff circumference range differs slightly (13.0-21.0 cm), it is comparable to other cleared similar devices (K211288: 13.5-21.5 cm) and meets the same accuracy standards (IEC 80601-2-30 laboratory and ISO 81060-2 clinical). Non-essential differences in display material, power supply, dimensions, and weight do not affect safety or effectiveness and comply with applicable standards. Clinical testing on 85 subjects demonstrated accuracy within ISO 81060-2 acceptable limits with no adverse events, confirming substantial equivalence to the predicate.