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510(k) Data Aggregation

    K Number
    K181211
    Device Name
    Human Tecar HCR 1002
    Manufacturer
    Date Cleared
    2018-09-10

    (126 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIBELL S.r.l

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Human Tecar HCR 1002 is a temporary diathermy device for topical heating in order to increase the patient's tissue temperature for treating: relief of pain, muscle spasms, increase in local circulation. The device has also been designed to provide massage aiming to temporarily reduce the cellulite appearance.
    Device Description
    Not Found
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