BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ManaFlexx 2 (model: MF002-RX, MF002-OTC)

    K Number: K231569 · Decision Nov 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    7
    Review Days
    156

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ManaFlexx 2 (model: MF002-RX, MF002-OTC)
    K Number
    K231569
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Manamed, Inc.
    Date Received
    May 31, 2023
    Decision Date
    November 3, 2023
    Product Code
    NUH
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NUH), ordered by most recent decision date.

    TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENS/EMS device (GUSE01)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENS&EMS (HZ9151B, HZ9151C, HZ9151D)

    FDA 510(k)
    FDA Class 2 ·Neurology

    VEINOPLUS Back

    FDA 510(k)
    FDA Class 2 ·Neurology

    Transcutaneous Electrical Nerve Stimulator (RJTENS-2)

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Manamed, Inc.

    K Number Device Name
    K222098 ManaSport+
    K210284 ManaSport
    K211253 PlasmaWave
    K200353 ManaFlow
    K200351 PlasmaFlight
    K160318 PlasmaFlow