VRNT— 510(k) K254004
Substantially EquivalentCognifisense, Inc.
FDA 510(k) clearance K254004 for VRNT, Substantially Equivalent on 2026-04-10. Applicant: Cognifisense, Inc.. Device class: 2.
Summary
VRNT from Cognifisense is filed under QRA, virtual reality behavioral therapy devices for pain relief. The code covers devices that deliver behavioral therapy for patients with pain through a virtual reality display running software that holds the therapy content.
Class II, 21 CFR 890.5800, filed as a Special 510(k). The record lists Neurology as the advisory panel and Physical Medicine as the review panel.
The company filed from Sunnyvale, California. Review took 116 days (December 15, 2025 to April 10, 2026).
Clearance details
- Applicant
- Cognifisense, Inc.
- Product code
- Product code QRA
- Device class
- Class 2
- Regulation
- 21 CFR 890.5800
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sunnyvale, CA, US
Recent devices under product code QRA
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