# K080283: Ideal Life Gluco-Manager GMM 0001 Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Jun 27, 2008 after 144 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: 1 generation back to K061181 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061181: Achtung Blood Glucose Monitoring System, Model TD-4207, Taidoc Technology Corporation (2006) Summary page 1.

## Indications for use
The IDEAL LIFE Gluco-Manager GMM 0001 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in this system can be used only during steady-state blood glucose conditions. This system offers Bluetooth wireless communication function which is able to transfer historical data in the memory to other devices, such as PC or IDEAL LIFE POD TM.

Source page: https://510kreport.com/device/K080283
Methodology: https://510kreport.com/methodology