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510(k) Data Aggregation

    K Number
    K142340
    Device Name
    Infrared Therapy System
    Date Cleared
    2014-12-02

    (103 days)

    Product Code
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beijing Huatai Healthcare Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HW-1000 Infrared Therapy System is intended to emit energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and for the temporary relaxation of muscles.
    Device Description
    The HW-1000 Infrared Therapy System is an effective, drug-free and non-invasive device which can deliver 850-950nm infrared energy through light emitting diodes (LED) mounted in the therapy pads (the same as light panels, but different expressions). Each pad has 66 diodes. The device consists of mainframe, which contains the user interface panel, the power supply, and the output jack used to connect pad to provide output. and therapeutic pads. When working, the plug of therapeutic pads is connected with the output jack of mainframe and the therapy pads are fixed on the surface of skin directly with matched bandages to provide heating.
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