QMY

Computerized Behavioral Therapy Device For Treating Symptoms

Product code

QMY

Device name

Computerized Behavioral Therapy Device For Treating Symptoms

Device class

Class 2

21 CFR

21 CFR 876.5960

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

A computerized behavioral therapy device for treating symptoms of gastrointestinal conditions is a prescription device intended to provide a computerized version of condition-specific therapy as an adjunct to standard of care treatments to patients with gastrointestinal conditions.

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