K211463 is an FDA 510(k) clearance for the Regulora. This device is classified as a Computerized Behavioral Therapy Device For Treating Symptoms (Class II - Special Controls, product code QMY).
Submitted by Metame Health, Inc. (Chicago, US). The FDA issued a Cleared decision on November 24, 2021, 197 days after receiving the submission on May 11, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5960. A Computerized Behavioral Therapy Device For Treating Symptoms Of Gastrointestinal Conditions Is A Prescription Device Intended To Provide A Computerized Version Of Condition-specific Therapy As An Adjunct To Standard Of Care Treatments To Patients With Gastrointestinal Conditions..
| 510(k) Number | K211463 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2021 |
| Decision Date | November 24, 2021 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | QMY - Computerized Behavioral Therapy Device For Treating Symptoms |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5960 |
| Definition | A Computerized Behavioral Therapy Device For Treating Symptoms Of Gastrointestinal Conditions Is A Prescription Device Intended To Provide A Computerized Version Of Condition-specific Therapy As An Adjunct To Standard Of Care Treatments To Patients With Gastrointestinal Conditions. |