QXC

Diabetes Digital Therapeutic Device

Product code

QXC

Device name

Diabetes Digital Therapeutic Device

Device class

Class 2

21 CFR

21 CFR 880.5735

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).