Diabetes Digital Therapeutic Device

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

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown