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510(k) Data Aggregation

    K Number
    K240292
    Device Name
    Transcutaneous Electrical Nerve Stimulator (9029SCM)
    Date Cleared
    2024-03-25

    (53 days)

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

    Hong Kong Etech Groups Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TENS (Mode 1~6) To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. EMS (Mode 1~6) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    1)Stylish appearance, compact size, humanized design for easy portability. 2)TENS and EMS modes with 6 different modes each, catering to various treatment needs and a wider range of users. 3)Dual-channel output, allowing control of intensity for each channel. 4)Unique combination of electric pulses for a different sensory experience. 5)LCD display for clear and easy use. 6)Powered by three AAA batteries (size 7), providing long-lasting usage and convenient for home and travel use. 7) The electrode patches used with the device are previously cleared under K221589 for safety use. The main unit delivers the electrical
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