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510(k) Data Aggregation

    K Number
    K241509
    Device Name
    TENS&EMS units (SM9109A, SM9109B)
    Manufacturer
    Plexus Yoga LLC Dba Chirp
    Date Cleared
    2024-06-27

    (30 days)

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

    Plexus Yoga LLC Dba Chirp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TENS (mode 1-3) The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS (mode 4-6) The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
    Device Description
    Not Found
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