QZA · Body Temperature Sensing Software
General Hospital · 21 CFR 880.2915 · Class 2
Overview
| Product Code | QZA |
|---|---|
| Device Name | Body Temperature Sensing Software |
| Regulation | 21 CFR 880.2915 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data. The Body Temperature Software (BTS) App is a software-only mobile medical application intended for over-the-counter (OTC) use with compatible mobile computing platforms that includes a general purpose infrared sensor for the intermittent determination of human body temperature on people of all ages.
Classification Rationale
Class II (special controls). The device is classified under 21 CFR 880.2915.
Special Controls
In combination with the general controls of the FD&C Act. the body temperature sensing software is subject to the following special controls:
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243778 | Body Temperature Software (BTS) | Fitbit, LLC | Feb 13, 2025 | SESE |
| DEN230050 | Body Temperature Software (BTS) | Fitbit, LLC | Dec 15, 2023 | DENG |
Top Applicants
- Fitbit, LLC — 2 clearances
