QMY · Class II · 21 CFR 876.5960

FDA Product Code QMY: Computerized Behavioral Therapy Device For Treating Symptoms

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.

Leading manufacturers include Mahana Therapeutics, Inc. and Metame Health, Inc..

3
Total
2
Cleared
145d
Avg days
2020
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Computerized Behavioral Therapy Device For Treating Symptoms Devices (Product Code QMY)

3 devices
1–3 of 3
Cleared Nov 24, 2021
Regulora
K211463
Metame Health, Inc.
Gastroenterology & Urology · 197d
Cleared Jun 02, 2021
Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)
K211372
Mahana Therapeutics, Inc.
Gastroenterology & Urology · 29d

About Product Code QMY - Regulatory Context

510(k) Submission Activity

3 total 510(k) submissions under product code QMY since 2020, with 2 receiving FDA clearance (average review time: 145 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

QMY devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →