BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RICH-MAR AUTOPRISM INFRARED LAMP

    K Number: K040679 · Decision May 7, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    43
    Review Days
    53

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    Basic Information

    Device Name
    RICH-MAR AUTOPRISM INFRARED LAMP
    K Number
    K040679
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rich-Mar Corp.
    Date Received
    March 15, 2004
    Decision Date
    May 7, 2004
    Product Code
    ILY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ILY Lamp, Infrared, Therapeutic Heating

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    Other Clearances by Rich-Mar Corp.

    K Number Device Name
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    K021483 RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
    K013770 MODIFICATION TO: WINNER ST-2 STIMULATOR
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    K012848 WINNER CM4 COMBINATION UNIT
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    K982544 RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES
    K952089 RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE
    K950564 RICH-MAR US-II ULTRASOUND
    Search all 43 clearances from Rich-Mar Corp. →