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510(k) Data Aggregation

    K Number
    K021472
    Device Name
    HMS-DHR-3 NEUROMUSCULAR STIMULATOR
    Manufacturer
    HOME MEDICAL SERVICES
    Date Cleared
    2002-08-06

    (90 days)

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

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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 - 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
    Device Description
    Not Found
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    K Number
    K021496
    Device Name
    HMS-DHR-3 NEUROMUSCULAR STIMULATOR
    Manufacturer
    HOME MEDICAL SERVICES
    Date Cleared
    2002-08-06

    (89 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
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    Applicant Name (Manufacturer) :

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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN
    Device Description
    Not Found
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    K Number
    K003231
    Device Name
    HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3
    Manufacturer
    HOME MEDICAL SERVICES
    Date Cleared
    2001-01-12

    (87 days)

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

    HOME MEDICAL SERVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994062
    Device Name
    HMS NEUROMUSCULAR STIMULATOR
    Manufacturer
    HOME MEDICAL SERVICES, INC.
    Date Cleared
    2000-04-10

    (131 days)

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

    HOME MEDICAL SERVICES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE INDICATIONS FOR USE OF THIS POWERED MUSCLE STIMULATOR FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS: - Relaxation of muscle spasms - Prevention of 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
    Device Description
    HMS Neuromuscular Stimulator, Model HMS-3
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