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510(k) Data Aggregation
K Number
K100524Device Name
POLYTEL(R) APT MODEL: PWA-08-01
Manufacturer
POLYMAP WIRELESS, LLC
Date Cleared
2010-05-24
(89 days)
Product Code
DRG
Regulation Number
870.2910Why 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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K Number
K091296Device Name
POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09
Manufacturer
POLYMAP WIRELESS
Date Cleared
2009-07-17
(74 days)
Product Code
NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
POLYMAP WIRELESS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Polytel GMA (models PWR-08-06, PWR-08-07, and PWR-08-09) are remote communications link devices intended to be used to wirelessly transmit glucose meter readings from a compatible Blood Glucose Monitor to a compatible cellular phone, such as the Nokia N73 or access point, such as the Polytel® APT. The receiving device, in turn, sends the readings to the healthcare provider in another location. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
Device Description
The Polytel® GMA is a telemedicine device that uses Bluetooth technology to transmit data from a glucose monitor to compatible access points such as a personal computer, standalone device or cellular phone with Bluetooth capability. It is connected to the glucose meter by a phono jack and uses short-range low power wireless transmission (Bluetooth v2.0) to send the data to Bluetooth compatible access point. The unit is battery powered.
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K Number
K070559Device Name
POLYMAP PWR-08-03
Manufacturer
POLYMAP WIRELESS
Date Cleared
2007-06-29
(122 days)
Product Code
NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
POLYMAP WIRELESS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Polymap PWR-008-03 is a remote communications link intended to be used to wirelessly transmit glucose meter readings from a Blood Glucose Monitor to a compatible access point or cellular phone, such as the Nokia 6620. The device does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
Device Description
The PWR-08-03 is a telemedicine device that uses Bluetooth technology to transmit data from a glucose monitor to compatible access points such as a personal computer or cellular phone with Bluetooth capability. It is connected to the glucose meter by a phono jack and uses short-range low power wireless transmission (Bluetooth VI .2) to send the data to a Bluetooth compatible access point. The unit is battery powered.
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