510(k) DEN220058
DEN220058 is an FDA 510(k) premarket notification submitted by Better Therapeutics for the device "BT-001". The FDA issued a decision of De Novo Granted on July 7, 2023. The device falls under product code QXC (Diabetes Digital Therapeutic Device), a Class II device regulated under 21 CFR 880.5735.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 7, 2023
- Date Received
- September 21, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diabetes Digital Therapeutic Device
- Device Class
- Class II
- Regulation Number
- 880.5735
- Review Panel
- CH
- Submission Type
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.