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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
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    XF Agencija Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Nooro Body & Foot Stimulator). This document does not contain the specific information you requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

    A 510(k) clearance letter confirms that a device is substantially equivalent to a legally marketed predicate device, but it does not typically include the detailed technical study reports or statistical analysis that would contain the information you are asking for. Those details would be part of the original 510(k) submission, which is not publicly available in this format.

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