# K091296: Polytel Gma, Models PWR-08-67, PWR-08-07, PWR-08-09

- Pathway: 510(k) (Abbreviated)
- Applicant: Polymap Wireless
- Decided: Jul 17, 2009 after 74 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070559: Polymap PWR-08-03, Polymap Wireless (2007) Summary page 2.
- K061328: Think Positive Diabetes Management System (T+Diabetes System), E-San Limited (2006) Summary page 2.

## Indications for 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.

Source page: https://510kreport.com/device/K091296
Methodology: https://510kreport.com/methodology