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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K183371
Device Name Deka Tiac 1
Applicant
El..En. Electroic Engineering Spa
Via Baldanzese, 17
Calenzano,  IT 50041
Applicant Contact Paolo Peruzzi
Correspondent
El..En. Electroic Engineering Spa
Via Baldanzese, 17
Calenzano,  IT 50041
Correspondent Contact Paolo Peruzzi
Regulation Number878.4400
Classification Product Code
PBX  
Date Received12/06/2018
Decision Date 12/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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