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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K263010
Device Name ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
Applicant
inomed Medizintechnik GmbH
Im Hausgruen 29
Emmendingen,  DE 79312
Applicant Contact Johannes Hoerth
Correspondent
inomed Medizintechnik GmbH
Im Hausgruen 29
Emmendingen,  DE 79312
Correspondent Contact Johannes Hoerth
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
ETN   GWE   GWJ   GWQ   IKN  
Date Received08/28/2026
Decision Date 09/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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