Not Cleared Direct

DEN210014 - EaseVRx (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN210014 · Appliedvr, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2021
Decision
231d
Days
Class 2
Risk

DEN210014 is an FDA 510(k) submission (not cleared) for the EaseVRx. Classified as Virtual Reality Behavioral Therapy Device For Pain Relief (product code QRA), Class II - Special Controls.

Submitted by Appliedvr, Inc. (Van Nuys, US). The FDA issued a Not Cleared (DENG) decision on November 16, 2021 after a review of 231 days.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5800 - the FDA physical medicine device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Physical Medicine review framework.

View all Appliedvr, Inc. devices

Submission Details

510(k) Number DEN210014 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 30, 2021
Decision Date November 16, 2021
Days to Decision 231 days
Submission Type Direct
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 115d · This submission: 231d
Pathway characteristics

Device Classification

Product Code QRA Virtual Reality Behavioral Therapy Device For Pain Relief
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.