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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nystagmograph
510(k) Number K260566
Device Name SMARTVERTIGO™ Vestibular Assessment System
Applicant
VertigoDx, Inc.
3911 Concord Pike #8030, Smb#68155
Wilmington,  DE  19803
Applicant Contact Trevor Meyerowitz
Correspondent
Imangel Consulting, Inc.
4738 SW 13th Ct.
Deerfield Beach,  FL  33442
Correspondent Contact Jerry Sudduth
Regulation Number882.1460
Classification Product Code
GWN  
Date Received02/19/2026
Decision Date 07/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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