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510(k) Data Aggregation

    K Number
    K040193
    Device Name
    MODEL GST-1
    Manufacturer
    MEDICAL EQUIPMENT DEVICE SPECIALISTS
    Date Cleared
    2004-04-27

    (90 days)

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

    MEDICAL EQUIPMENT DEVICE SPECIALISTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AS A POWERED MUSCLE STIMULATOR - 1. Relaxation of muscle spasms - Prevention or retardation of disuse atrophy 2 . - Increasing local blood circulation - 4. Muscle re-education - Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis - 6. Maintaining or increasing range of motion AS A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR - 1 . Symptomatic relief of chronic intractable pain
    Device Description
    Not Found
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    K Number
    K032055
    Device Name
    MEDS-4-INF+
    Manufacturer
    MEDICAL EQUIPMENT DEVICE SPECIALISTS
    Date Cleared
    2003-10-03

    (93 days)

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

    MEDICAL EQUIPMENT DEVICE SPECIALISTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AS A POWERED MUSCLE STIMULATOR - 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 AS A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR - SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN AS AN INTERFERENTIAL CURRENT STIMULATOR - SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN - SYMPTOMATIC RELIEF OF ACUTE PAIN
    Device Description
    Not Found
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    K Number
    K023435
    Device Name
    MEDS-4 NEUROMUSCULAR STIMULATOR
    Manufacturer
    MEDICAL EQUIPMENT DEVICE SPECIALISTS
    Date Cleared
    2003-01-13

    (90 days)

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

    MEDICAL EQUIPMENT DEVICE SPECIALISTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN
    Device Description
    Not Found
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    K Number
    K023439
    Device Name
    MEDS-4 NEUROMUSCULAR STIMULATOR
    Manufacturer
    MEDICAL EQUIPMENT DEVICE SPECIALISTS
    Date Cleared
    2003-01-13

    (90 days)

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

    MEDICAL EQUIPMENT DEVICE SPECIALISTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS : - 1 . Relaxation of muscle spasms - 2. Prevention or retardation of disuse atrophy - 3. Increasing local blood circulation - 4 . Muscle re-education - Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis - Maintaining or increasing range of motion 6.
    Device Description
    MEDS-4 NEUROMUSCULAR STIMULATOR
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    K Number
    K023443
    Device Name
    MEDS-3 NEUROMUSCULAR STIMULATOR
    Manufacturer
    MEDICAL EQUIPMENT DEVICE SPECIALISTS
    Date Cleared
    2003-01-13

    (90 days)

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

    MEDICAL EQUIPMENT DEVICE SPECIALISTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN
    Device Description
    Not Found
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    K Number
    K023446
    Device Name
    MEDS-3 NEUROMUSCULAR STIMULATOR
    Manufacturer
    MEDICAL EQUIPMENT DEVICE SPECIALISTS
    Date Cleared
    2003-01-13

    (90 days)

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

    MEDICAL EQUIPMENT DEVICE SPECIALISTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS : - Relaxation of muscle spasms 1. - 2. Prevention or retardation of disuse atrophy - Increasing local blood circulation 3 . - Muscle re-education 4 . - Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis - Maintaining or increasing range of motion 6.
    Device Description
    MEDS-3 NEUROMUSCULAR STIMULATOR
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