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510(k) Data Aggregation

    K Number
    K243334
    Device Name
    Nooro Body & Foot Stimulator (SM9141, SM9142)
    Manufacturer
    XF Agencija Limited
    Date Cleared
    2024-11-22

    (29 days)

    Product Code
    NUH, GZJ, IPF, NGX, NYN
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    XF Agencija Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Over-The-Counter Use: TENS: The device (SM9141, SM9142) is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and feet, due to strain from exercise or normal household and work activities and also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. EMS/NMES: The device (SM9141, SM9142) is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, feet and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. The device (SM9141, SM9142) is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities. For Prescription Use: Device (SM9141, SM9142): TENS: - Symptomatic relief and management of chronic, intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain - Relief of pain associated with arthritis EMS/NMES: - Temporary relaxation of muscle spasm - Prevention or retardation of disuse atrophy - Muscle re-education - Maintaining or increasing range of motion - Increase of local blood flow in the treatment area - Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles
    Device Description
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