Regulora®
Basic Information
- Brand Name
- Regulora®
- Primary DI
- 00860005970209
- Version / Model
- GDH-1
- Catalog Number
- 60005-97020
- Company Name
- Metame Health, Inc.
- Labeler DUNS
- 080168265
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-29
- Public Version
- 1
- Public Version Date
- 2022-05-09
- Public Version Status
- New
- Public Device Record Key
- 77eb2ff6-85ed-426e-93c8-249160d86afa
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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QMY | Computerized Behavioral Therapy Device For Treating Symptoms | Gastroenterology, Urology | 876.5960 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860005970209 | GS1 |
Customer Contacts
- Phone
- 888-463-8263
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211463 | 000 |