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510(k) Data Aggregation

    K Number
    K041146
    Device Name
    CONTROL SOLUTIONS, INC., MODEL CS3102 HVG
    Date Cleared
    2004-06-08

    (36 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTROL SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - Relaxation of muscle spasm . - Increasing local blood circulation . - Maintaining or increasing range of motion • - Preventing or retarding disuse atrophy . - Muscle re-education . - Intusion is outcales. .
    Device Description
    CS3102 High Voltage Galvanic Stimulator
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    K Number
    K993420
    Device Name
    CONTROL SOLUTIONS INC, MODEL CS3101
    Date Cleared
    2000-07-19

    (281 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTROL SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - . Interferential Current Therapy Modes: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain. - Neuro-Muscular Stimulator Modes: Relaxation of muscle spasm, increasing local blood circu-. lation, maintaining or increasing range of motion, preventing or retarding disuse atrophy, muscle re-education, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
    Device Description
    Not Found
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