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510(k) Data Aggregation

    K Number
    K181211
    Device Name
    Human Tecar HCR 1002
    Manufacturer
    UNIBELL S.r.l
    Date Cleared
    2018-09-10

    (126 days)

    Product Code
    PBX
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the Human Tecar HCR 1002 device. It describes the device's indications for use and regulatory classification but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

    Therefore, I cannot provide the requested information based on the given input. The document is primarily a regulatory communication confirming clearance, not a technical report or study summary.

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