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510(k) Data Aggregation

    K Number
    K200560
    Device Name
    InBody
    Manufacturer
    InBody Co. Ltd.
    Date Cleared
    2021-01-06

    (308 days)

    Product Code
    DXN, DXQ
    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 subject device is a manual blood pressure (BP) monitor, and requires the user to listen for Korotkoff sounds to determine systolic and diastolic pressure. Further, patients whose Korotkoff sounds are not clear or absent, such as children younger than 3 years of age, will not be suitable for the subject device. Pulse rate is also measured.
    Device Description
    This device can be used to measure blood pressure and pulse rate non-persistently using the Korotkoff sound method of measuring blood pressure in vitro. The user can measure the blood pressure using this device and cuff, stethoscope. Basically, it has the same function as a conventional mercury sphygmomanometer. However, instead of using harmful mercury to the human body, it displays the pressure on the LCD screen, so that the blood pressure can be measured harmlessly to the human body. In addition, using the 'Mark' function can conveniently display the systolic and diastolic pressures. And using its backlight, the user can measure blood pressure in the dark place. If air pressure exceeds 320mmHg, it will automatically exhaust quickly. If an emergency occurs during the measurement, pressing On/Off button will turn off the equipment and allow rapid exhaust. The device is for use by medical professional. The testing person supplies their own stethoscope, which is required for making the measurements.
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    K Number
    K200442
    Device Name
    InBody
    Manufacturer
    InBody Co. Ltd.
    Date Cleared
    2020-12-04

    (284 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 Inbody blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 17cm - 42cm. The models of BP170, BP160 and BP160B are designated as both Prescription use and Over-the-counter use. The model of BPBIO250 is designated as Prescription use only.
    Device Description
    All models have this common feature: Automatic blood pressure measurement using the oscillometric technique. This is the same method as our predicate. We have employed essentially the same technology as we used in our previous model (the predicate) but have packaged the unit differently in order to make it more portable. Instead of having a built in blood pressure cuff, we have moved that component outside of the unit so that now it plugs in to the measurement unit in the same way a large number of similar devices are designed. Instead of AC line operation only, the units can run on primary or on rechargeable batteries. The predicate device used an 8 bit microcontroller with 128Kbytes of in-system programmable flash memory. The BP170 series and the BPBIO250 use 32 bit microcontrollers with 128Kbytes of programmable flash. Most of the measurement software has been re-used from our predicate device and is virtually the same between the two new sets of models. The BP170 is a fully automatic portable battery operated blood pressure monitor using the oscillometric technique which comes with batteries, a standard cuff, a storage pouch, and a user's manual. BPBIO250 This product is a professional automatic blood pressure monitor used by medical professionals. 5 measurement modes can be selected according to various medical environments. Rechargeable batteries can be used without replacing batteries. The User can measure blood pressure even in dark environments. - This blood pressure monitor has cuffs of various sizes. So, User can measure the blood pressure and measure pulse rate to children and adult patients whose arm circumferences are between 17 cm and 42 cm.
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