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510(k) Data Aggregation

    K Number
    K210383
    Device Name
    Wrap Accessory Electrodes
    Manufacturer
    Hi-Dow International Inc.
    Date Cleared
    2021-11-12

    (276 days)

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

    Hi-Dow International Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wrap Accessory Electrodes are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The wrap accessory electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as back, neck, shoulder, elbow, wrist, knee and foot.
    Device Description
    The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as back, neck, shoulder, elbow, wrist, knee and foot.
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    K Number
    K202337
    Device Name
    Pulsed electromagnetic field wrap
    Manufacturer
    Hi-Dow International Inc.
    Date Cleared
    2020-12-15

    (120 days)

    Product Code
    ILX, IRT
    Regulation Number
    890.5290
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hi-Dow International Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. It is also indicated for the temporary relief of minor muscle and pain associated with overexertion, strains, sprains and arthritis.
    Device Description
    Pulsed electromagnetic field wrap
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    K Number
    K190617
    Device Name
    Wrap accessory electrodes
    Manufacturer
    Hi-Dow International Inc.
    Date Cleared
    2019-07-02

    (113 days)

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

    Hi-Dow International Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wrap accessory electrodes, available in a glove style, are cutaneous electrodes intended to be used with legally marketed TENS or EMS stimulating devices. The Wrap accessory electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include the hands (gloves) and feet (socks).It is intended for adult patients.
    Device Description
    Wrap accessory electrodes, available in a glove style, are cutaneous electrodes intended to be used with legally marketed TENS or EMS stimulating devices. The Wrap accessory electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact.
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    K Number
    K102598
    Device Name
    HI-DOW-XP
    Manufacturer
    HI-DOW INTERNATIONAL INC.
    Date Cleared
    2011-05-13

    (245 days)

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

    HI-DOW INTERNATIONAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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. It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    The JQ-5C is a portable; battery powered (3.7VDC) multi function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device. Double channels that effectively transfers your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 6 modes of operation.
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