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
Cleared
Nov 24, 2021
Regulora
Metame Health, Inc.
Gastroenterology & Urology
197d
Cleared
Jun 02, 2021
Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)
Mahana Therapeutics, Inc.
Gastroenterology & Urology
29d
Not Cleared
Nov 25, 2020
Parallel
Mahana Therapeutics, Inc.
Gastroenterology & Urology
209d
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.