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510(k) Data Aggregation

    K Number
    K102278
    Device Name
    QUADRA BLOC TENS PLUS
    Date Cleared
    2011-10-20

    (435 days)

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

    GRADIENT TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Quadra Bloc TENS Model 101 is intended for use in relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. This is a prescription device and should be used under continued medical supervision.
    Device Description
    The Quadra Bloc TENS, Model 101 is a battery powered portable TENS device. The Quadra Bloc TENS, Model 101 is a prescription device that is intended for use in relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. The device is specially designed to be small, portable and lightweight so as to not interfere with users movements and/or functions. The electronics unit consists of a housing that contains a battery compartment, display, entry keypad, electronic system, and output channels. The Quadra Bloc TENS, Model 101 uses four AA alkaline batteries. The display is a single line 16-character alphanumeric display. The entry keypad is used for turning the device on/off, setting parameters on the device and controlling operation. There are two output channels, designated Left and Right. They have a constant phase relation with each other but are independently set for amplitude. There is a separate two-wire cable for each channel. The electronics consists of a microprocessor (HP) to control and sequence all functions. It also reads the keyboard inputs. Output amplitude and display are under HP control. The electronics also boost the battery voltage to the level required for the stimulation pulse, as well as controls the timing for the pulse width and frequency. The QuadraBloc TENS + Electrode, to be used in conjunction with the QuadraBloc TENS Model 101 is a PMI electrode with an attached QuadraBloc permanent magnet.
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    K Number
    K062547
    Device Name
    QUADRA BLOC TENS, MODEL 101
    Date Cleared
    2007-03-21

    (203 days)

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

    GRADIENT TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Quadra Bloc TENS Model 101 is intended for use in relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. This is a prescription device and should be used under continued medical supervision.
    Device Description
    The Quadra Bloc TENS, Model 101 is a battery powered portable TENS device. The Ouadra Bloc TENS. Model 101 is a prescription device that is intended for use in relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. The device is specifically designed to be small, portable and lightweight so as to not interfere with users movements and/or functions. The electronics unit consists of a housing that contains a battery compartment, display, entry keypad, electronic system, and output channels. The Quadra Bloc TENS, Model 101 uses four AA alkaline batteries. The display is a single line 16-character alphanumeric display. The entry keypad is used for turning the device on/off, setting parameters on the device, and controlling operation. There are two output channels, designated Left and Right. They have a constant phase relation with each other but are independently set for amplitude. There is a separate two-wire cable for each channel. The electronics consists of a microprocessor (uP) to control and sequence all functions. It also reads the keyboard inputs. Output amplitude and display are under uP control. The electronics also boost the battery voltage to the level required for the stimulation pulse, as well as controls the timing for the pulse width and frequency.
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