510(k) DEN210014

Device
EaseVRx
Applicant
Appliedvr, Inc.
510(k) number
DEN210014
Product code
QRA
Decision
Unknown (DENG)
Decision date
2021-11-16
Date received
2021-03-30
Regulation
890.5800
Classification name
Virtual Reality Behavioral Therapy Device For Pain Relief
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Direct
Third party reviewed
N

Applicant Contact#

Contact
Jafar Shenasa
Address
16760 Stagg St., Suite 216 Van Nuys CA US 91406 91406

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code QRA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254004VRNTCognifisense, Inc.2026-04-10
K251519RelieVRx (Pico G3)Appliedvr2025-08-13
K243417RelieVRxAppliedvr2024-12-04
K230814VRNTCognifisense, Inc.2023-10-31
K230825Smileyscope System (Therapy Mode)Smileyscope Holding, Inc.2023-09-25