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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Virtual Reality Behavioral Therapy Device For Pain Relief
510(k) Number K230814
Device Name VRNT
Applicant
CognifiSense, Inc.
1271 Lakeside Drive, Suite 3121
Sunnyvale,  CA  94085
Applicant Contact Tassilo Baeuerle
Correspondent
CognifiSense, Inc.
1271 Lakeside Drive, Suite 3121
Sunnyvale,  CA  94085
Correspondent Contact Tassilo Baeuerle
Regulation Number890.5800
Classification Product Code
QRA  
Date Received03/24/2023
Decision Date 10/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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