# K100524: Polytel (R) Apt Model: Pwa-08-01

- Pathway: 510(k) (Abbreviated)
- Applicant: Polymap Wireless, LLC
- Decided: May 24, 2010 after 89 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K864318 (1987). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041816: RTX3320PSTN Wireless Telehealth Gateway, Rtx Healthcare A/S (2004) Summary page 1.
- K080538: Ideal Life Pod (Model Ilp 0001), Ideal Life, Inc. (2008) Summary page 1.

## Indications for 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.

Source page: https://510kreport.com/device/K100524
Methodology: https://510kreport.com/methodology