Body Temperature Software

Primary DI

00810073612327

Basic UDI-DI Code

081007361FB611NE

Reference

FB611

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Fitbit LLC

The BTS app is a mobile medical application that runs on qualified mobile computing platforms such as a Google Pixel smartphone. When you open the app and follow the on-screen instructions, you can use your smartphone to take body temperature measurements. All objects emit infrared radiation; the hotter an object is, the more infrared radiation energy it emits. Qualified Pixel platforms have an infrared (IR) sensor, located on the back of the smartphone below the camera flash. To take a body temperature reading, you must swipe the IR sensor across your forehead, as instructed in the app. When you swipe the IR sensor across your forehead, it senses the IR being emitted from your skin and converts it into a body temperature measurement that is then shown in the app. Syncing the BTS app data with the Fitbit app allows users to track body temperature over time, as well as access educational resources related to body temperature. Body temperature data is stored on the smartphone for 7 days on qualified Pixel platforms and can be sent securely to the Fitbit app.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).