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510(k) Data Aggregation

    K Number
    K213295
    Device Name
    C.C. LIFE 21
    Manufacturer
    21 Equipment S.R.L.
    Date Cleared
    2022-11-17

    (412 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 C.C.Life 21 device with C-Life handle (RF) is indicated for the temporary relief of minor muscle aches and pain temporary relief of muscle spasm, and temporary improvement of local blood circulation.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a medical device called "C.C. Life 21". It does not contain information about acceptance criteria, device performance studies, or AI assistance. The letter confirms that the device is substantially equivalent to a legally marketed predicate device for the temporary relief of minor muscle aches and pain, muscle spasm, and temporary improvement of local blood circulation.

    Therefore, I cannot provide the requested information based on the provided text. The document is solely a regulatory approval and does not detail the technical performance or validation studies of the device.

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