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510(k) Data Aggregation

    K Number
    K213788
    Device Name
    TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
    Date Cleared
    2022-05-06

    (151 days)

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

    Dongguan Bohuikang Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TENS & EMS STIMULATOR has two functions and can be used for arm, shoulder, neck, back, waist, abdomen, hip, and leg. TENS: It is used for the symptomatic relief of chronic intractable pain and the temporary relief of pain associated with sore and aching muscles in the arm, shoulder, neck, back, waist, abdomen, hip and leg due to strain from exercise or normal household and work activities. EMS: It is used for relaxation of muscle spasm, increase of local blood flow circulation, prevention of disuse atrophy, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
    Device Description
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