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510(k) Data Aggregation

    K Number
    K221589
    Device Name
    Starly pad
    Manufacturer
    Shenzhen Xingyuanli Technology Co., Ltd.
    Date Cleared
    2023-03-24

    (296 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Xingyuanli Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Starly pad is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The Starly pad is for OTC (Over-The-Counter) or Prescription use. The Starly pad is for adults only.
    Device Description
    The Starly pad consists of Insulation backing layer, Adhesive layer, Conducting film, Gel layer, Protective film and Snap fastener.
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