The KD-936 Fully Automatic Wireless Blood Pressure Monitor is a non-invasive blood pressure measurement system intended for use by medical professionals or at home. The device measures diastolic and systolic blood pressures and pulse rate using a non-invasive technique with an inflatable cuff wrapped around the upper arm. The device is designed according to ANSIAAMI SP10-manual, electronic or automated sphygmomanometers and has a cuff circumference limited to 22cm-48cm.
The device operates by integrating with an iPhone, iPod, or iPad, and its function is achieved through oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and the measurement results can be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user. The device also obtains the function of averaging the measurement results.
According to the 510(k) summary, the device is substantially equivalent to the iHealth BP3 Fully Automatic Electronic Blood Pressure Monitor, but with a different appearance, memory time, and user interface. The measure process is also changed, as the new device gets the measurement results during deflation, whereas iHealth BP3 gets the result during the inflation period.
The user manual includes sections on the device information, classification, predicate device information, device description, intended use, technological characteristics comparison, non-clinical and clinical tests performed, performance summary, and comparison to the predicate device and the conclusion.
Manual:
Download: User Manual for KD-936 Fully Automatic Wireless Blood Pressure Monitor
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