BT-001 Diabetes Digital Therapeutic Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- DEN220058 FDA 510(k)
- FDA Product Code
- QXC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5735 FDA 510(k)
- Regulation Number
- 880.5735 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The Bt-001 Diabetes Digital Therapeutic Device is a prescription-only digital therapeutic device that provides cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. It is intended to be used adjunctively with standard of care. The device is classified as a class 2 device with the regulation number 880.5735.
The Bt-001 is supplied as a single device and is indicated for use in patients with type 2 diabetes. It is authorized by the FDA with a 510K clearance. The device is used in a general hospital setting and has a product code of QXC. The device is for single use and is not specified as MRI safe or sterile in the provided data.
Frequently asked questions
What is the BT-001 device used for?
The BT-001 device is used to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes, as an adjunct to standard care.
Is the BT-001 device sterile?
The provided data does not specify that the BT-001 device is sterile.
Can the BT-001 device be used multiple times?
No, the BT-001 device is intended for single use.
What type of setting is the BT-001 device typically used in?
The BT-001 device is typically used in a general hospital setting.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Better Therapeutics Completes Pivotal Trial of BT-001 for Type 2 ..., Better Therapeutics Receives FDA Authorization for AspyreRx™ to Treat ..., PDF Novo CLASSIFICATION REQUEST FOR BT-001 - accessdata.fda.gov, Better Therapeutics files for FDA approval of diabetes DTx
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN220058 | Class II | Active |
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Manufacturer
- Manufacturer
- Better Therapeutics
Sources (1)
- FDA 510(k) DEN220058 24 fields · synced Sep 21, 2026