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510(k) Data Aggregation

    K Number
    K023036
    Device Name
    CARE ETS
    Manufacturer
    CARE REHAB AND ORTHOPAEDIC
    Date Cleared
    2003-06-19

    (280 days)

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

    CARE REHAB AND ORTHOPAEDIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Statement of Indication of Use (in EMG Mode): - Biofeedback - Relaxation Training - Muscle Re-education Statement of Ladication of Use (in NMS Mode): The Care ETS 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 stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion. - Stroke Rehabilitation, using muscle re-education techniques
    Device Description
    A portable NMS device for muscle re-education.
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    K Number
    K022417
    Device Name
    CARE STIM
    Manufacturer
    CARE REHAB AND ORTHOPAEDIC
    Date Cleared
    2003-04-10

    (260 days)

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

    CARE REHAB AND ORTHOPAEDIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Classic Stim 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 muscle re-education.
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    K Number
    K020637
    Device Name
    SELECT STIM
    Manufacturer
    CARE REHAB AND ORTHOPAEDIC
    Date Cleared
    2002-05-28

    (90 days)

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

    CARE REHAB AND ORTHOPAEDIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Select Stim 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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