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510(k) Data Aggregation

    K Number
    K121702
    Device Name
    ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE
    Manufacturer
    ORTHOCOR MEDICAL
    Date Cleared
    2013-05-06

    (332 days)

    Product Code
    ILX
    Regulation Number
    890.5290
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOCOR MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.
    Device Description
    The OrthoCor General Use Device (marketed as the OrthoCor Active Device) is a portable (battery operated) non-invasive shortwave diathermy medical device. Through the use of resonators and two applicator coils, the device applies electromagnetic energy at a radio frequency (RF) of 27.12MHz for the treatment of medical conditions by means other than the generation of deep heat within body tissues, i/e/. by athermal means. The OrthoCor General Use Device delivers the pulsed RF signal of 6.5±0.5µWs/cm³ to the tissue target via inductive coupling using two applicator coils. It is a general use device and can be positioned on the body with a wrap designed to hold the device in place at the location that requires treatment.
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    K Number
    K092044
    Device Name
    ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE
    Manufacturer
    ORTHOCOR MEDICAL
    Date Cleared
    2009-12-18

    (165 days)

    Product Code
    ILX, IMD
    Regulation Number
    890.5290
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOCOR MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OrthoCor Knee System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. Temporary relief of minor muscular and joint aches and pains associated with over-exertion, strains, sprains, and arthritis.
    Device Description
    The OrthoCor Active Knee System is a portable (battery operated) non-invasive shortwave diathermy medical device which applies electromagnetic energy at a radio frequency (RF) of 27.12 MHz for the treatment of medical conditions by means other than the generation of deep heat within body tissues, i.e., by athermal means. The OrthoCor Knee System delivers the pulsed RF signal of 6.5±0.5µWs/cm to the tissue target via the inductive coupling with an applicator coil. The system also includes disposable, single-use, air activated OrthoPods that provide heat. The OrthoPods are snapped into medial and lateral slots on the knee wrap. Treatment may occur directly through dressings, clothing, casts, compression garments or supports.
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    K Number
    K091996
    Device Name
    ORTHOCOR KNEE SYSTEM BASIC
    Manufacturer
    ORTHOCOR MEDICAL
    Date Cleared
    2009-12-15

    (166 days)

    Product Code
    ILX
    Regulation Number
    890.5290
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOCOR MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.
    Device Description
    The OrthoCor Knee System is a portable (battery operated) non-invasive shortwave diathermy medical device which applies electromagnetic energy at a radio frequency (RF) of 27.12 MHz for the treatment of medical conditions by means other than the generation of deep heat within body tissues, i.e., by athermal means. The OrthoCor Knee System delivers the pulsed RF signal of 6.5±0.5µWs/cm3 to the tissue target via the inductive coupling with an applicator coil. OrthoPods are snapped into medial and lateral slots on the knee wrap to activate the system. Treatment may occur directly through dressings, clothing, casts, compression garments or supports. The OrthoCor device is substantial equivalent to the Ivivi Torino II device in parameters, treatment and power
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