YUWELL® Electronic Blood Pressure Monitor (YE650AR)

The YUWELL® Electronic Blood Pressure Monitor (YE650AR) is a rechargeable, automatic, noninvasive upper-arm blood pressure measurement system for over-the-counter use. It measures systolic and diastolic blood pressure and pulse rate in patients older than 12 years using the oscillometric method with an inflatable cuff, and is suitable for home or healthcare facility use.

The subject device shares the same principle of operation, measurement site, cuff circumference, blood pressure measuring range and precision, pressurization source, pressure sensor, and operating environment as the predicate. Key differences include: one cuff type versus multiple for the predicate; broader age environment; lithium battery versus AA batteries; AC adapter output capability; and additional features such as memory, Bluetooth, and three-color backlit display not present in the predicate.

ISO 81060-2, Cybersecurity in Medical Devices and FCC, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, ISO 10993-1/5/10/23, and IFU requirement testing were performed to support substantial equivalence.

The subject device is substantially equivalent because it has the same intended use and technological characteristics as the predicate device (Electronic Blood Pressure Monitor YE620B, YE620D, YE660E, YE660F, YE680B). Minor differences in battery type, additional features, and intended patient population do not constitute a new intended use, as clinical investigation requirements for patients older than 12 years are essentially the same per ISO 81060-2.