QXC
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Diabetes Digital Therapeutic Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5735
- Medical specialty
- General Hospital
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| BT-001 (DEN220058) | Better Therapeutics | 2023-07-07 |
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