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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K201458
Device Name Scrambler Therapy Technology (Model ST-5A)
Applicant
Delta International Services & Logistics S.R.L
Piazza Adriana 4
Rome,  IT 00193
Applicant Contact Mariella Giorgieri
Correspondent
Delta International Services & Logistics S.R.L
Piazza Adriana 4
Rome,  IT 00193
Correspondent Contact Mariella Giorgieri
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/01/2020
Decision Date 12/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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