Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Virtual Reality Behavioral Therapy Device For Pain Relief
510(k) Number K254004
Device Name VRNT
Applicant
Cognifisense, Inc.
1271 Lakeside Dr.
Apt. 3121
Sunnyvale,  CA  94085
Applicant Contact Amanda Way
Correspondent
Cognifisense, Inc.
1271 Lakeside Dr.
Apt. 3121
Sunnyvale,  CA  94085
Correspondent Contact Amanda Way
Regulation Number890.5800
Classification Product Code
QRA  
Date Received12/15/2025
Decision Date 04/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Physical Medicine
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-