# Diabetes Digital Therapeutic Device
> **Product code: QXC** · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5735
## Classification
- **FDA Product Code:** QXC
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 880.5735
- **Review panel:** CH
- **Medical specialty:** General Hospital
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QXC)
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