# K211372: Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)

- Pathway: 510(k) (Special)
- Applicant: Mahana Therapeutics, Inc.
- Decided: Jun 2, 2021 after 29 days
- Product code: QMY (Computerized Behavioral Therapy Device For Treating Symptoms)
- Device class: 2
- Regulation: 21 CFR 876.5960
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN200029 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200029: Parallel, Mahana Therapeutics, Inc. (2020) Summary page 4.

## Indications for use
Parallel™ is a prescription-only digital therapeutic intended to provide cognitive behavioral therapy for adults aged 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Parallel is indicated as a 3 month treatment for patients with IBS. Parallel treats IBS by reducing the severity of symptoms and is intended to be used together with other IBS treatments.

Source page: https://510kreport.com/device/K211372
Methodology: https://510kreport.com/methodology