DEN210014 is an FDA 510(k) submission for the EaseVRx. This device is classified as a Virtual Reality Behavioral Therapy Device For Pain Relief (Class II - Special Controls, product code QRA).
Submitted by Appliedvr, Inc. (Van Nuys, US). The FDA issued a Not Cleared (DENG) decision on November 16, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5800. A Virtual Reality Behavioral Therapy Device For Pain Relief Is A Device Intended To Provide Behavioral Therapy For Patients With Pain. Therapy Is Administered Via A Virtual Reality Display Which Utilizes A Software Program Containing The Behavioral Therapy Content..
| 510(k) Number | DEN210014 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 30, 2021 |
| Decision Date | November 16, 2021 |
| Days to Decision | 231 days |
| Submission Type | Direct |
| Review Panel | Physical Medicine (PM) |
| Summary | - |
| Product Code | QRA - Virtual Reality Behavioral Therapy Device For Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5800 |
| Definition | A Virtual Reality Behavioral Therapy Device For Pain Relief Is A Device Intended To Provide Behavioral Therapy For Patients With Pain. Therapy Is Administered Via A Virtual Reality Display Which Utilizes A Software Program Containing The Behavioral Therapy Content. |