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510(k) Data Aggregation

    K Number
    K021905
    Device Name
    CLASSIC NMS
    Manufacturer
    CARE REHAB, INC.
    Date Cleared
    2002-09-05

    (87 days)

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

    CARE REHAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Classic NMS is recommended for use for the following conditions: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical simulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion
    Device Description
    A portable NMS device for pain control.
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    K Number
    K020516
    Device Name
    CARE IFC PLUS
    Manufacturer
    CARE REHAB, INC.
    Date Cleared
    2002-05-16

    (90 days)

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

    CARE REHAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain
    Device Description
    A portable Interferential device for pain control
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    K Number
    K020437
    Device Name
    CLASSIC TENS
    Manufacturer
    CARE REHAB, INC.
    Date Cleared
    2002-03-15

    (35 days)

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

    CARE REHAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.
    Device Description
    A portable TENS device for pain control.
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    K Number
    K984025
    Device Name
    CARE TENS
    Manufacturer
    CARE REHAB, INC.
    Date Cleared
    1999-02-10

    (90 days)

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

    CARE REHAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.
    Device Description
    A portable TENS device for pain control.
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