510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K254004Substantially Equivalent

Vrnt

CognifiSense, Inc., Sunnyvale CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K254004 is the FDA 510(k) clearance record for VRNT, a class II device, cleared for Cognifisense, Inc. on under FDA product code QRA (Virtual Reality Behavioral Therapy Device For Pain Relief). FDA's definition for product code QRA reads: "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...". FDA records list 2 510(k) clearances for Cognifisense, Inc., from to . As of , FDA records show no recalls naming K254004.

Clearance record

Decision date
Received
(116 days to decision)
Product code
QRA Virtual Reality Behavioral Therapy Device For Pain Relief
Regulation
21 CFR 890.5800
Device class
Class II
Review panel
Neurology
Applicant
Cognifisense, Inc. 1271 Lakeside Dr., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QRA

Trailing 12 months
1 clearance under product code QRA in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QRA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260