K243417 is an FDA 510(k) clearance for the RelieVRx. This device is classified as a Virtual Reality Behavioral Therapy Device For Pain Relief (Class II - Special Controls, product code QRA).
Submitted by Appliedvr (Van Nuys, US). The FDA issued a Cleared decision on December 4, 2024, 30 days after receiving the submission on November 4, 2024.
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 | K243417 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2024 |
| Decision Date | December 04, 2024 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| 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. |