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510(k) Data Aggregation

    K Number
    K240168
    Device Name
    N7-S
    Manufacturer
    Nuga Medical Co., Ltd.
    Date Cleared
    2024-09-12

    (234 days)

    Product Code
    JFB, IRP
    Regulation Number
    890.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nuga Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the N7-S is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for; -Temporary relief of minor muscle and joint pain, and stiffness. -Temporary relief of minor joint pain associated with arthritis. -The temporary increase in local circulation where applied. -Relaxation of muscle. The air massager module of N7-S is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas. The air massager module of N7-S stimulates kneading of tissues by using an inflatable garment.
    Device Description
    The N7-S is a multi-function physical therapy device offering muscle relaxation through heat therapy and massage. It has an internal heating unit (smart module), and this module, equipped with four individual heating elements, delivers targeted heat therapy to the cervical, thoracic, and lumbar vertebrae. An auxiliary heating unit is used for the heating units located on both arms to boost the heating effect. For more focused heat therapy and massage, 9-ball projector, Abdominal heating pad are also available. Additionally, it includes an air massager module that features air compression technology to deliver a relaxing and therapeutic massage.
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