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510(k) Data Aggregation

    K Number
    K212377
    Device Name
    Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
    Manufacturer
    Ningbo MedKinetic Medical Device Co., Ltd.
    Date Cleared
    2022-04-15

    (256 days)

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

    Ningbo MedKinetic Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used by adults only for temporary relief of pain associated with sore and aching muscles in the shoulder, wast, back, neck, arm, and leg, due to strain from exercise or normal household work activities and suitable for home use.
    Device Description
    Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
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