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510(k) Data Aggregation

    K Number
    K191940
    Device Name
    Palm NRG cellulite and muscle toning body device
    Manufacturer
    Heat In A Click
    Date Cleared
    2020-11-03

    (473 days)

    Product Code
    PBX,GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Palm NRG cellulite and muscle toning body device

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Palm NRG cellulite body device (model: Palm NRG body device) is intended for delivering non thermal RF combined with massage for temporary reduction in the appearance of cellulite.

    Device Description

    Palm NRG cellulite body device (model: Palm NRG body device)

    AI/ML Overview

    This FDA 510(k) clearance letter for the "Palm NRG cellulite body device" indicates that the device is substantially equivalent to a legally marketed predicate device. However, the provided document does not contain any information regarding acceptance criteria, the study proving the device meets these criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

    The letter focuses on regulatory compliance, outlining the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and other relevant regulations. It confirms the device's classification and lists the indications for use.

    Therefore, I cannot provide the requested information based on the given input document. The document simply states the intended use of the device: "Palm NRG cellulite body device (model: Palm NRG body device) is intended for delivering non thermal RF combined with massage for temporary reduction in the appearance of cellulite." The specifics of how this claim was substantiated through studies are not present in this regulatory clearance letter.

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