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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    21 Equipment S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    21 Equipment S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
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