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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 K253237
Device Name Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
Applicant
Elde Medikal Sanayi ve Ticaret Anonim Sirketi
Necip Fazil Bulvari Keyap Carsi Sitesi No: 44
D-1 Blok Dukkan No: 53/2
Umraniye/Istanbul,  TR 34775
Applicant Contact Nurettin Eren
Correspondent
Elde Medikal Sanayi ve Ticaret Anonim Sirketi
Necip Fazil Bulvari Keyap Carsi Sitesi No: 44
D-1 Blok Dukkan No: 53/2
Umraniye/Istanbul,  TR 34775
Correspondent Contact Deniz Ozgulbas
Regulation Number882.1320
Classification Product Code
GXY  
Date Received09/29/2025
Decision Date 05/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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