Cleared Special

K243417 - RelieVRx (FDA 510(k) Clearance)

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

K243417 · Appliedvr · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
30d
Days
Class 2
Risk

K243417 is an FDA 510(k) clearance for the RelieVRx. Classified as Virtual Reality Behavioral Therapy Device For Pain Relief (product code QRA), Class II - Special Controls.

Submitted by Appliedvr (Van Nuys, US). The FDA issued a Cleared decision on December 4, 2024 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5800 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Appliedvr devices

Submission Details

510(k) Number K243417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2024
Decision Date December 04, 2024
Days to Decision 30 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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.