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Regulora®

FDA UDI

Class II (US FDA UDI)

by Metame Health, Inc.

Identity

Trade Name
Regulora® FDA UDI
Generic Name
Mindfulness/behavioural therapy software, non-clinician-consultative FDA UDI
Device Name
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. FDA UDI
Model / Reference
GDH-1 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
60005-97020 FDA UDI
Primary DI / UDI-DI
00860005970209 FDA UDI
510(k) Number
K211463 FDA UDI
FDA Product Code
QMY FDA UDI
GMDN Term
Mindfulness/behavioural therapy software, non-clinician-consultative FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5960 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mindfulness/behavioural therapy software, non-clinician-consultative

Regulora® by Metame Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mindfulness/behavioural therapy software, non-clinician-consultative.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Metame Health, Inc.

Sources (1)

  • FDA UDI 77eb2ff6-85ed-426e-93c8-249160d86afa 36 fields · synced May 31, 2026