510(k) K211372
K211372 is an FDA 510(k) premarket notification submitted by Mahana Therapeutics, Inc. for the device "Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)". The FDA issued a decision of Substantially Equivalent on June 2, 2021. The device falls under product code QMY (Computerized Behavioral Therapy Device For Treating Symptoms), a Class II device regulated under 21 CFR 876.5960. Mahana Therapeutics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 2021
- Date Received
- May 4, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computerized Behavioral Therapy Device For Treating Symptoms
- Device Class
- Class II
- Regulation Number
- 876.5960
- Review Panel
- GU
- Submission Type
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.