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510(k) Data Aggregation

    K Number
    K041172
    Device Name
    BASBA E-MACHINE
    Manufacturer
    Date Cleared
    2004-11-18

    (198 days)

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

    BASBA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Basba E-Machine is intended for use as a symptomatic relief and management of chronic and acute pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain. The Basba E-Machine is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
    Device Description
    The Basba E-Machine is a non-invasive, transcutaneous electrical stimulation device, which is intended for use as an adjunctive treatment for individuals suffering from chronic intractable pain. The system consists of a.TENS Unit, AC-DC adapter to power the unit and a serial RS-232 connection cable. The Unit is approximately 17 cm x 15 cm x 4 cm. Two light emitting diodes (LED) are located on the faceplate of the Unit. The green LED indicates the working status of the device and the red LED is the power indicator. There are four sockets located on the faceplate of the Unit: three of them labeled "OUT" provide the output electrical current for 3 different types of connectors and the fourth socket is the ground socket labeled GND.
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