DEN220058 is an FDA 510(k) submission for the BT-001. This device is classified as a Diabetes Digital Therapeutic Device (Class II - Special Controls, product code QXC).
Submitted by Better Therapeutics (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on July 7, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 880.5735. 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) Number | DEN220058 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 21, 2022 |
| Decision Date | July 07, 2023 |
| Days to Decision | 289 days |
| Submission Type | Direct |
| Review Panel | Chemistry (CH) |
| Summary | - |
| Product Code | QXC - Diabetes Digital Therapeutic Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5735 |
| 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. |