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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K223738
Device Name Alpha Control Liner System (ACLS)
Applicant
Coapt
303 W. Institute Pl.
Suite 200
Chicago,  IL  60610
Applicant Contact Blair Lock
Correspondent
Coapt
303 W. Institute Pl.
Suite 200
Chicago,  IL  60610
Correspondent Contact Blair Lock
Regulation Number882.1320
Classification Product Code
GXY  
Date Received12/14/2022
Decision Date 01/11/2023
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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