DeviceClearance

Product code QMY— Gastroenterology, Urology

Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)

Classification name
Computerized Behavioral Therapy Device For Treating Symptoms
Device class
Class 2
Regulation
21 CFR 876.5960
Advisory panel
Gastroenterology, Urology
Total cleared
3
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QMY under 21 CFR 876.5960, via openFDA

Market context for product code QMY

FDA has cleared 3 devices under product code QMY between 2020 and 2021, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QMY

Recent clearances under product code QMY

Data sourced from openFDA. This site is unofficial and independent of the FDA.