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510(k) Data Aggregation

    K Number
    K150557
    Device Name
    Podimetrics Remote Temperature Monitoring System
    Manufacturer
    Date Cleared
    2015-10-08

    (218 days)

    Product Code
    Regulation Number
    890.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Podimetrics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Podimetrics Remote Temperature Monitoring System™ (RTM System™) is intended to be used by a patient in conjunction with a healthcare professional or caretaker for periodic evaluation of the temperature over the soles of the feet for signs of inflammation. It will provide information indicating when the patient and healthcare provider should communicate for further evaluation and treatment regarding any persistent localized inflammation observed on the feet via the electronic sensing system and remote visualization of its data. The Podimetrics RTM System™ is intended to be used under the direction of a healthcare professional as an adjunct to, and not in replacement of, self-examination and periodic foot care and examination conducted by a healthcare professional and does not diagnose any specific disease state.
    Device Description
    The Podimetrics RTM System™ is designed to help a patient and healthcare professional periodically evaluate the temperature over the soles of the feet for signs of inflammation. This evaluation may be helpful for determining when the patient and healthcare provider should communicate for physical examinations or care in addition to normally scheduled visits. The system is comprised of the Podimetrics Mat and the Thermogram Explorer™ internet application. The Podimetrics Mat is about the same size and shape as a floor mat and placed on the floor of the patient's home. The patient stands on the mat once per day for about 20 seconds to collect a thermal scan of the soles of the feet. The thermal scan is recorded electronically via 2-dimensional array of temperature-sensitive resistors covering the top surface of the mat and the data is transmitted by an internal cellular modem to a remote server via cellular network. The thermal scan data is processed and stored on the remote server and is displayed in Thermogram Explorer™, an internet application. The patient and healthcare professional can use Thermogram Explorer™ to access the thermograms and evaluate them for signs of inflammation. If any signs are observed, the patient can see the healthcare professional for a physical examination.
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