510(k) K254004
K254004 is an FDA 510(k) premarket notification submitted by Cognifisense, Inc. for the device "VRNT". The FDA issued a decision of Substantially Equivalent on April 10, 2026. 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. Cognifisense, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2026
- Date Received
- December 15, 2025
- Clearance Type
- Special
- 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.