AccessGUDID - DEVICE: Regulora® (00860005970209)

GUDID

Device Identifier (DI) Information

Brand Name: Regulora®
Version or Model: GDH-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60005-97020
Company Name: Metame Health, Inc.

Primary DI Number: 00860005970209
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080168265 *Terms of Use

Device Description: Regulora® is prescription-only digital therapeutic (PDT) software indicated for use in the treatment of abdominal pain due to Irritable Bowel Syndrome (IBS). The Regulora program is Software as a Medical Device (SaMD) that resides on and is accessed through the user’s mobile device and can be executed at home. Regulora digitizes scripted therapist-administered gut-directed psychotherapy and provides 7 unique treatment sessions, each lasting ~30 minutes, every other week over 12 weeks. The treatment sessions are designed to first induce deep physical and autonomic relaxation which is followed by metaphorical storytelling and a combination of direct and indirect suggestions targeted at somatic control mechanisms. Regulora also provides for IBS symptom tracking, which patients can share with their doctor in the management of their IBS.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65220	Mindfulness/behavioural therapy software, non-clinician-consultative	A software program intended to be used with an off-the-shelf computer/tablet/smartphone to help treat affective/mood disorders, stress, and/or other disorders related to or caused by these, by providing a patient with on-screen therapeutic exercises (e.g., mindfulness, mental imagery, cognitive behavioural therapy) often with educational information; it is not dedicated to exposure therapy. It is intended for use by a patient at home and is not based on consultation with a clinician.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
QMY	Computerized Behavioral Therapy Device For Treating Symptoms

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211463	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 77eb2ff6-85ed-426e-93c8-249160d86afa
Public Version Date: May 09, 2022
Public Version Number: 1
DI Record Publish Date: April 29, 2022