Data / Medical devices / United States / Appliedvr
Appliedvr: FDA-registered device maker in Van Nuys, CA, United States, 2 510(k) clearances
Appliedvr is registered with the FDA (registration 3021071568) in Van Nuys, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 4, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021071568
- Address
- 16760 Stagg St Unit 216, Van Nuys, CA, United States, 91406
- Owner or operator
- AppliedVR (10083591)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 3, 2021
- Registered through
- 2026
- Brand names listed
- EaseVRx, RelieVRx
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Virtual Reality Behavioral Therapy Device For Pain Relief | QRA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 4, 2024 | K243417 | RelieVRx | QRA | Substantially Equivalent | Appliedvr | accessdata.fda.gov |
| November 16, 2021 | DEN210014 | EaseVRx | QRA | Unknown | Appliedvr, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 27, 2023 | 92389 | Class II | Completed | RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief. | There is the potential for the program software to malfunction which will not allow it to move forward to the next session. | accessdata.fda.gov |
Updated December 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.