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510(k) Data Aggregation

    K Number
    K252769
    Date Cleared
    2025-10-02

    (30 days)

    Product Code
    Regulation Number
    870.1130
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Upper Arm Electronic Blood Pressure Monitor, Models FC-BP107, FC-BP123, FC-BP125, FC-BP126,FC-BP127, FC-BP116 are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.

    Device Description

    The subject device, Upper Arm Electronic Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor which can be driven by 4 AA batteries / 4×AAA batteries or type-C USB (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.

    The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor.

    The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x120 sets of measurement values can be stored automatically. The earliest record will be deleted automatically to save the latest measurement value when more than the measurement values. The unit also calculates an average reading based on the values of the latest 3 times measurement.

    This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not.

    This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips.

    During blood pressure measurement, if the body moves excessively, the body motion detection icon will appear on the display.

    Sleeve with self-check: Detects whether the cuff is worn correctly. If the pressure can exceed 30mmHg within 15 seconds, this Sleeve with self-check icon will light up.

    During the blood pressure measurement decrease process, if a pulse wave is detected, this Pulse Detected Icon will flash at the same frequency as the peak of the pulse wave appears.

    The device detects an Irregular HeartBeat (IRB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values.

    The device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device(except model FC-BP107).

    There is a maximum pressure safety setting at 300 mmHg, when the pressure is more than 300mmHg, the device will exhaust fast automatically.

    No operation for 2 minute the device will shut down automatically.

    The device includes model FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116. Model FC-BP107 and FC-BP116 can be powered by internal battery (4×AA batteries, 6.0V DC) or Type-C port 5VDC 1A, other models can be powered by internal battery (4×AAA batteries, 6.0V DC) or Type-C port 5VDC 1A.

    All models have same MCU, Air pump, Solenoid valve and blood pressure core algorithm except for PCB layout, Display screen, function of the Button, dimension and power supply.

    The subject devices (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) and the predicate devices (FC-BP100, FC-BP101, FC-BP102, FC-BP110, FC-BP111, FC-BP112) share the same schematic, circuitry, critical components, and measurement algorithm.

    For the differences between the subject device models, the differences are PCB layout difference (physical board shape and/or component arrangement differences), Display screen, function of the Button, dimension, and power supply.

    These changes are mainly cosmetic and do not affect the electrical design, safety, or essential performance of the devices.

    AI/ML Overview

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