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510(k) Data Aggregation

    K Number
    K171026
    Device Name
    Mytens Model: BW-TSX
    Manufacturer
    Bewell Connect Corp.
    Date Cleared
    2017-11-01

    (210 days)

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

    Bewell Connect Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    Mytens Model: BW-TSX
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