DEN200029 is an FDA 510(k) submission for the Parallel. This device is classified as a Computerized Behavioral Therapy Device For Treating Symptoms (Class II - Special Controls, product code QMY).
Submitted by Mahana Therapeutics, Inc. (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on November 25, 2020.
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 | DEN200029 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 30, 2020 |
| Decision Date | November 25, 2020 |
| Days to Decision | 209 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| 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. |