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510(k) Data Aggregation

    K Number
    K061452
    Device Name
    TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM
    Date Cleared
    2006-07-12

    (48 days)

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

    TUNG FU ELECTRIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TF-BP01"" blood pressure monitor is intended for use in the home to measure systolic and diastolic blood pressures and pulse rate on adults aged 18 and older. Measurements are obtained using a non-invasive technique by placing an inflatable cuff around the wrist. The cuff circumference is 5.25 to 7.75 inches.
    Device Description
    The TF-BP01™ Blood Pressure Monitor is a wrist blood pressure monitor and uses the oscillometric method to measure the blood pressure. The device includes setting button, function button, LCD display, start/stop button, recall memory button, and wrist cuff.The symbols display on LCD include month, date, hour, minute, systolic rate, diastolic rate, pulse rate, pulse symbol, blood pressure unit, battery display, error symbol, memory record.
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    K Number
    K042107
    Device Name
    TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001
    Date Cleared
    2005-03-09

    (217 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    TUNG FU ELECTRIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - Specific indications: it is used for the symptomatic relief and management of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems. - Clinical settings: should be used under the instruction or prescriptions by . qualified health professionals prior to the applications of the device at home or hospital facilities.
    Device Description
    Not Found
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