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510(k) Data Aggregation

    K Number
    K231174
    Device Name
    BPBIO750
    Manufacturer
    InBody Co, Ltd.
    Date Cleared
    2023-08-02

    (99 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    InBody Co, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BPBIO750 is a digital monitor intended for use in measuring blood pressure and pulse rate in user population with left and right upper arm circumference ranging from 22 cm (8.7-inch to 16.5-inch). The systolic blood pressure and diastolic blood pressure are measured by non-invasive blood pressure ("NIBP") measuring method. The BPBIO750 may provide useful clinical information about the current health status of not only the users who are diagnosed with hypertension but also those who are not diagnosed with hypertension.
    Device Description
    The InBody BPBIO750 is a kiosk-type, automated, single upper-arm cuff oscillometric BP monitor developed for self-measurement of BP in public spaces. It is designed for BP measurements on either the right or left upper arm and has a fixed tubular opening to insert the user's arm, with an integral single-arm cuff, which when inflated surrounds the upper arm. It is suitable for arm circumference range 22-42 cm. The device has an elbow groove to ensure correct positioning of the arm and measures BP during inflation. A wide LED screen presents systolic and diastolic BP, heart rate and time of measurement, and print-out of these data is provided automatically to the user. When the device is turned on, an auto zero calibration is performed, as well as a functional self-check of the air pressure change according to motor operation, the initial cuff position, and the motor load according to the cuff movement. Its weight is 7.1 kg, width 299 mm, depth 547 mm, height 485 mm, and has power supply through cable (AC 250 V, 10A). Calibration is recommended once every 12 months.
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    K Number
    K221764
    Device Name
    InBody Blood pressure monitor, Model BPBIO480KV
    Manufacturer
    InBody Co, Ltd.
    Date Cleared
    2022-10-07

    (112 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    InBody Co, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This blood pressure monitor is designed to measure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 22 cm - 42 cm.
    Device Description
    The BPBIO480KV is a digital monitor intended for use in measuring blood pressure and pulse rate in user population with upper arm circumference ranging from 22cm (8.6-inch to 16.5-inch). The systolic blood pressure and diastolic blood pressure are measured by non-invasive blood pressure ("NIBP") measuring method and also by utilizing the Auto auscultation method and Oscillometric method. The BPBIO480KV may provide useful clinical information about the current health status of not only the users who are diagnosed with hypertension but also those who are not diagnosed with hypertension. Warnings and cautions described in the user's manual should be observed at all times. Automated Auscultation is a method that combines the accuracy of auscultation, and the convenience of the Oscillometric method. To measure the blood pressure, wrap the cuff around the upper arm and inflate it to a pressure above the systolic pressure. Then slowly release the air to detect the Korotkoff sound signal and the pressure sensor signal, which you can listen with the stethoscope attached to the cuff, to measure the systolic and diastolic blood pressure. The Automated Auscultation applied to BPBIO480KV combines the accuracy of the auscultation method with the convenience of easy measurement. The signals are electronically processed to compensate for the possible errors in the auscultation method caused by movement, external noise, etc., enabling a more accurate blood pressure measurement. Included components are the main unit, a large and a medium size cuff, a users manual, an AC adapter, a power cord, and an internal rechargeable lithium rechargeable battery. Measurement methods: Auscultation and Oscillometric.
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