The following data is part of a De Novo classification by Appliedvr, Inc. with the FDA for Easevrx.
| DeNovo ID | DEN210014 |
| Device Name: | EaseVRx |
| Classification | Virtual Reality Behavioral Therapy Device For Pain Relief |
| Applicant | AppliedVR, Inc. 16760 Stagg St, Ste 216 Van Nuys, CA 91406 |
| Contact | Jafar Shenasa |
| Product Code | QRA |
| CFR Regulation Number | 890.5800 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Physical Medicine |
| Classification Advisory | Neurology |
| Type | Direct |
| Date Received | 2021-03-30 |
| Decision Date | 2021-11-16 |
| Reclassification Order: | Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850038247010 | DEN210014 | 000 |
| 00850038247027 | DEN210014 | 000 |
| 00850038247041 | DEN210014 | 000 |
| 00850038247034 | DEN210014 | 000 |
| 00850038247058 | DEN210014 | 000 |
| 00850038247065 | DEN210014 | 000 |
| 00850038247096 | DEN210014 | 000 |
| 00850038247089 | DEN210014 | 000 |
| 00850038247072 | DEN210014 | 000 |