510(k) DEN210014
DEN210014 is an FDA 510(k) premarket notification submitted by Appliedvr, Inc. for the device "EaseVRx". The FDA issued a decision of De Novo Granted on November 16, 2021. The device falls under product code QRA (Virtual Reality Behavioral Therapy Device For Pain Relief), a Class II device regulated under 21 CFR 890.5800. Appliedvr, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 16, 2021
- Date Received
- March 30, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Virtual Reality Behavioral Therapy Device For Pain Relief
- Device Class
- Class II
- Regulation Number
- 890.5800
- Review Panel
- PM
- Submission Type
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.