QXC — Diabetes Digital Therapeutic Device Class II
FDA product code QXC covers "Diabetes Digital Therapeutic Device", a Class II medical device regulated under 21 CFR 880.5735. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QXC
- Device Class
- Class II
- Regulation Number
- 880.5735
- Submission Type
- Review Panel
- CH
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220058 | better therapeutics | BT-001 | July 7, 2023 |