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510(k) Data Aggregation

    K Number
    K250033
    Device Name
    Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)
    Manufacturer
    Guangzhou Pinzhi Medical Technology Co., LTD
    Date Cleared
    2025-04-07

    (90 days)

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

    Guangzhou Pinzhi Medical Technology Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PZ-2622 is TENS and EMS Stimulator Mode 1-12: TENS: This mode 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), and lower extremities (leg) due to strain from exercise or normal household work activities. Mode 13-24: EMS: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. PZ-2622E (Mode 1-24) is EMS Stimulator This device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. PZ-2622T (Mode 1-24) is TENS Stimulator This 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), and lower extremities (leg) due to strain from exercise or normal household work activities.
    Device Description
    Not Found
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