510(k) K251519

Device

RelieVRx (Pico G3)

Applicant

Appliedvr

510(k) number

K251519

Product code

QRA

Decision

Substantially Equivalent (SESE)

Decision date

2025-08-13

Date received

2025-05-16

Regulation

890.5800

Classification name

Virtual Reality Behavioral Therapy Device For Pain Relief

Medical specialty

Neurology

Review panel

Neurology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N