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510(k) Data Aggregation

    K Number
    K143268
    Device Name
    TENS AND POWERED MUSCLE STIMULATOR
    Manufacturer
    SHENZHEN AS-TEC TECHNOLOGY CO., LTD
    Date Cleared
    2015-07-21

    (250 days)

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

    SHENZHEN AS-TEC TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transcutaneous Electrical Nerve Stimulation (TENS): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. Powered Muscle Stimulation (PMS): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
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