510(k) K243417
- Device
- RelieVRx
- Applicant
- Appliedvr
- 510(k) number
- K243417
- Product code
- QRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-04
- Date received
- 2024-11-04
- Regulation
- 890.5800
- Classification name
- Virtual Reality Behavioral Therapy Device For Pain Relief
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Michael Chibbaro
- Address
- 16760 St.Agg St. Van Nuys CA US 91406 91406
FDA Registration Numbers#
- 3021071568
- 3042903607
Source Documents#
Other 510(k) Records For Product Code QRA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254004 | VRNT | Cognifisense, Inc. | 2026-04-10 |
| K251519 | RelieVRx (Pico G3) | Appliedvr | 2025-08-13 |
| K230814 | VRNT | Cognifisense, Inc. | 2023-10-31 |
| K230825 | Smileyscope System (Therapy Mode) | Smileyscope Holding, Inc. | 2023-09-25 |
| DEN210014 | EaseVRx | Appliedvr, Inc. | 2021-11-16 |