LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K230459
    Device Name
    C.C. Life 21
    Manufacturer
    21 Equipment S.R.L.
    Date Cleared
    2023-10-19

    (240 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    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.

    The C.C.Life 21 device with C-Life Micro handle (TENS) is intended for facial stimulation and is indicated for cosmetic use.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for the device "C.C. Life 21". It primarily focuses on regulatory compliance, outlining general controls, additional controls, and relevant regulations.

    The document does not contain any information regarding:

    • Acceptance criteria for device performance.
    • The study that proves the device meets any acceptance criteria.
    • Specific details about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for testing or training, or training set sizes/ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

    Ask a Question

    Ask a specific question about this device

    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.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1