De Novo DEN210014

Device
EaseVRx
Contact
jafar shenasa
De Novo number
DEN210014
Product code
QRA
Regulation
890.5800
Classification name
virtual reality behavioral therapy device for pain relief
Decision
granted (DENG)
Decision date
2021-11-16
Date received
2021-03-30
Classification advisory
Neurology
Review advisory
Physical Medicine
Type
Direct

Current FDA Classification#

Product code
QRA
Device name
Virtual Reality Behavioral Therapy Device For Pain Relief
Medical specialty
Neurology
Device class
2
Regulation
890.5800
Implant
N
Life sustain/support
N