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510(k) Data Aggregation

    K Number
    K100524
    Device Name
    POLYTEL(R) APT MODEL: PWA-08-01
    Manufacturer
    POLYMAP WIRELESS, LLC
    Date Cleared
    2010-05-24

    (89 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMAP WIRELESS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Polytel® APT receives data wirelessly from compatible devices to transmit over the Internet or common telephone lines. The APT is an optional accessory to other Polytel® devices, including the various GMA (glucose meter accessory) models, blood pressure meter, weight scale and spot-check SpO2. The APT is intended to aid people at home and health care professionals to review and evaluate historical blood glucose, weight and blood pressure test results, to support effective health care management. The APT does not measure, interpret, or make any decisions with respect to any of the data it transports. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of appropriate healthcare professional. This device is not intended as a substitute for medical care. Any device certified by Polymap Wireless as compatible can use the Polytel® APT to forward its data. The device is not intended for emergency calls, and may not be used to send any real-time alarms or time-critical data. The device is not intended for use in systems set up for patients who need direct medical supervision or who might need emergency intervention. The APT and its compatible devices must be used in conjunction with a subscription to a compatible monitoring service. The monitoring service may distribute the APT to the patient; alternatively, the patient may acquire the APT and other compatible devices and subscribe to a compatible service. A list of compatible devices and services will be available on the Polymap Wireless website.
    Device Description
    The Polytel® APT device performs transmission of physiological patient information to and from wireless patient monitors and a remote data server healthcare facility over an encrypted dialup Internet connection. The APT, with its built-in telephone modem, transmits data over the public switched telephone network and the dial-up Internet. The APT is contained in a small plastic unit, containing two standard telephone jacks for connection to standard phone outlets, a 5V power input jack for connection to an AC adapter, and four indicator lights. The indicator lights are used to show the reception of a measurement from a transmitting device, to show when the telephone line is in use, and to indicate if there has been an error (delay) in transmission. Two server-side components are involved in the operation of the APT, the first providing a centralized configuration database, the second providing for data collection and translation to a standard protocol. The APT device is not used directly on a patient, nor attached electrically to any device that is used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.
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