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510(k) Data Aggregation
K Number
K150908Device Name
XM-01 Electronic Automatic Blood Pressure Monitor
Manufacturer
Date Cleared
2015-12-16
(257 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Sky Innovation Technology ( Shanghai) Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
XM-01 Automatic Electronic Blood Pressure Monitor is a home use digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 13.5 cm to 19.5 cm.
The device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Device Description
XM-01 Automatic Electronic Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. This is a home use device.
Measurement method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury nmometer. With a sensor, the microprocessor converts tiny alterations in cuff pressure to electrical signals, and analyze those signals to define the systolic and diastolic blood pressure and calculating heartbeat rate, which is a well-known technique in the market called the "Oscillometric method". The sensor also detect pulse rate at the same time.
XM-01 Automatic Electronic Blood Pressure Monitor achieves its function by integrating a single-mounted device hardware to a mobile application software, which is downloadable to a mobile device such as Apple or Android phone. As the hardware itself does not include a LCD or other display components, it is necessary for the device hardware to communicate with mobile devices containing the supporting software to constitute a complete blood pressure measurement system. This communication is realized through an embedded Bluetooth module.
The single-mounted device hardware is composed of the main unit and cuff unit. The cuff unit, which is applicable to wrist circumference approximately between 13.5 and 19.5 cm, includes the inflatable bladder and nylon/cotton/PVC shell. The main unit consists of the microprocessor, pressure sensor, pump, the electromagnetic deflation control valve and the battery. The subject device is powered by a 3.7V/400mAH lithium battery. The battery can be re-charged by either a DC5V 500mA charger or a USB cable.
The mobile application, downloadable to mobile devices such as Apple IOS or Android phone, receives measurement results from the single mounted device. The mobile App allows the test results to be displayed on the mobile devices (such as cell phone) for user review. It also transmits the data to the database in remote server for storage and future retrieval.
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