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510(k) Data Aggregation

    K Number
    K090542
    Device Name
    SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900
    Date Cleared
    2009-10-23

    (235 days)

    Product Code
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUN-RAIN SYSTEM CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SUN-RAIN Ultrasonic Therapy generates deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
    Device Description
    Ultrasonic equipment generates high frequency sound waves that are transferred to a specific body area via a round-headed probe. The sound waves travel deep into tissue and create gentle heat. As the probe glides over the skin's surface, sound waves penetrate the skin's surface causing soft tissues to creating deep heat. In turn, the heat induces vasodilatation: drawing blood into the target tissues. The generated deep heat is found to help relieve pain and reduce muscle spasms.
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    K Number
    K024013
    Device Name
    SUN-RAIN ULTRASONIC THERAPY, SU-100
    Date Cleared
    2003-10-31

    (331 days)

    Product Code
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUN-RAIN SYSTEM CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SU-100 generates deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
    Device Description
    Not Found
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    K Number
    K011913
    Device Name
    SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES
    Date Cleared
    2001-10-26

    (129 days)

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

    SUN-RAIN SYSTEM CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - Specific indications: used to apply an electrical current to electrodes on patient's skin to function as: Relaxation of muscle spasms; Prevention or retardation of disuse atrophy Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion. - Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.
    Device Description
    Not Found
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