# K211463: Regulora

- Pathway: 510(k) (Traditional)
- Applicant: Metame Health, Inc.
- Decided: Nov 24, 2021 after 197 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
Regulora™ is a prescription-only digital therapeutic device intended to provide behavioral therapy through gut-directed hypnotherapy for adults 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Regulora is indicated as a 3-month treatment for patients with abdominal pain due to IBS and is intended to be used together with other IBS treatments.

Source page: https://510kreport.com/device/K211463
Methodology: https://510kreport.com/methodology