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510(k) Data Aggregation

    K Number
    K013210
    Device Name
    TRUWAVE
    Manufacturer
    DAN MED, INC.
    Date Cleared
    2002-04-04

    (190 days)

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

    DAN MED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Management and symptomatic relief of chronic intractable pain, posttraumatic and post-surgical pain.
    Device Description
    Not Found
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    K Number
    K012885
    Device Name
    NEUROMOVE NM900
    Manufacturer
    DAN MED, INC.
    Date Cleared
    2001-11-08

    (72 days)

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

    DAN MED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stroke Rehab by Muscle Re-education Relaxation of Muscle Spasms Prevention of retardation of disuse atrophy Increase local blood circulation Muscle re-education Maintaining or increasing range of motion
    Device Description
    Not Found
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    K Number
    K010745
    Device Name
    EMS 3000
    Manufacturer
    DAN MED, INC.
    Date Cleared
    2001-06-27

    (106 days)

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

    DAN MED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991241
    Device Name
    IF8000
    Manufacturer
    DAN MED, INC.
    Date Cleared
    1999-11-02

    (204 days)

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

    DAN MED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In Interferential Mode: Symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain. In NMES Mode: 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 deep venous thrombosis. Maintaining or increasing range of motion.
    Device Description
    Not Found
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    K Number
    K972997
    Device Name
    AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION
    Manufacturer
    DAN MED, INC.
    Date Cleared
    1997-11-10

    (90 days)

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

    DAN MED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stroke Rehab by Muscle Reeducation Relaxation of muscle spasms. Prevention of retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Maintaining or increasing range of motion.
    Device Description
    Not Found
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    K Number
    K964738
    Device Name
    ELPHA 2000 CONTI
    Manufacturer
    DAN MED, INC.
    Date Cleared
    1997-08-14

    (274 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAN MED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrical stimulation of the pelvic floor muscles with the use of vaginal probe. The effect is strengthening the pelvic floor muscles and an activation of the central nervous system. Electrical stimulation of the pelvic floor muscles can reduce urinary incontinence among stress and urge incontinent adult females.
    Device Description
    Not Found
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