Diabetes Digital Therapeutic Device
The diabetes digital therapeutic device (product code QXC) is a prescription-use Class 2 software device in the General Hospital specialty (regulation 880.5735) that provides digital behavioral therapy to aid in the management of diabetes mellitus. Requiring 510(k) clearance, it is intended to provide a limited secondary benefit to patients by assisting them in managing their condition and is not intended to replace primary treatments such as diet/lifestyle changes or medication. It is not an implant and is not life-sustaining.
Basic Information
- Product Code
- QXC
- Device Class
- FDA class 2
- Regulation Number
- 880.5735
- Medical Specialty
- General Hospital
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
Definition
A diabetes digital behavioral therapeutic device is a prescription use software device that provides digital behavioral therapy to aid in the management of diabetes. This device is intended to provide limited secondary benefit to patients with diabetes mellitus by assisting them in managing their condition. This device is not intended to replace any primary treatment, such as diet/lifestyle changes or medication.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN220058 | BT-001 | Jul 07, 2023 | Unknown | Better Therapeutics |