Is Gmate ON FDA approved or cleared?
Partly. Gmate ON belongs to a product family by Philosys, Inc. that holds a 510(k) clearance, latest decision in 2015, but this exact variant or app is not named in the FDA record.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | Gmate ON |
|---|---|
| Maker | Philosys, Inc. |
| Care area | Diabetes & metabolism |
| What it does | Bluetooth-enabled glucose meter with smartphone app for diabetes tracking |
| FDA | 510(k), latest decision 2015 (product family) |
| Verification level | Product family authorised; this exact variant or app is not named (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | i-sens.com |
| Status | FDA verified |
| Last checked | 6 October 2026 |
Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Other apps in Diabetes & metabolism
- Accu-Chek Connect app
- AgaMatrix Diabetes Manager
- Bigfoot Unity™
- Biolinq Shine
- BlueStar®
- CeQur Simplicity
- Contour Diabetes App
- Dario Blood Glucose Monitor