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510(k) Data Aggregation

    K Number
    K060246
    Device Name
    INFREX
    Manufacturer
    JOHARI DIGITAL HEALTHCARE LTD.
    Date Cleared
    2006-05-05

    (94 days)

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

    JOHARI DIGITAL HEALTHCARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INFREX is indicated to be used for: - - Symptomatic relief and management of chronic intractable pain. - Adjunctive treatment in the management of post surgical and post-traumatic, Acute pain condition.
    Device Description
    INFREX is a Microcomputer controlled portable two channel electrical stimulator. It allows the treatment specifically tailored to the precise needs of the patient. The unique feature of this unit is that it is supplied with two removable packs of rechargeable batteries and an external charger. The user can put one battery pack in the unit for reatment and another spare pack can be charged outside the unit using the supplied external charger. This system facilitates the user to have charged batteries always available and the treatment can be aak any time. Often the units available in the market consume lot of power and batteries die fast. The Rubber Key Pad operation and LCD protocols makes the use and programming easy and simple. All the parameters remain in the system control except the amplitude & time selectable, which can be set by the patient himself. The ergonomic design makes this unit very comfortable to worn and carry.
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