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510(k) Data Aggregation

    K Number
    K061343
    Device Name
    INSPIRSTAR GLOVE ELECTRODE
    Manufacturer
    Date Cleared
    2006-05-31

    (16 days)

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

    INSPIRSTAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Inspirstar Glove Electrode is intended to for use with legally marketed electrostimulation devices such as TENS to deliver stimulation current for pain relief. Inspirstar Glove Electrode is cutaneous electrode to be used with legally marketed TENS stimulating device. The glove electrodes will deliver the stimulation signals generated by the stimulator to the skin with which they are contact.
    Device Description
    Inspirstar Glove Electrode is the conductive glove knitted from a continuous silver coated nylon yarn into the form of the glove. The conductivity is derived from the silver material of nylon yarn. Nylon yarn provides elasticity which can ensure skin contact. Inspirstar Glove Electrode has the same conductivity for dry or wet usage. The entire glove electrode is conductive having the resistance of less than 7 ohms per inch consistently.
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    K Number
    K060368
    Device Name
    INSPIRSTAR IS02 MICROCURRENT STIMULATOR
    Manufacturer
    Date Cleared
    2006-03-14

    (29 days)

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

    INSPIRSTAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Inspirstar IS02 Microcurrent Stimulator is intended to be used for the symptomatic relief of chronic intractable pain.
    Device Description
    Inspirstar IS02 Microcurrent Stimulator is a Microcurrent TENS device intended to be used for the symptomatic relief of chronic intractable pain. This product can generate low current intensity pulses at microampere level and frequency of pulses. The unit supports five pre-defined therapy programs. The current intensity, frequency, time, etc. are programmable by doctors.
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