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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 K200359
Device Name NuEra Tight, NuEra Tight EMS
Applicant
Bios S.R.L.
Via Guido Rossa 10/12
Vimodrone,  IT 20090
Applicant Contact Maurizio Bianchi
Correspondent
Bios S.R.L.
Via Guido Rossa 10/12
Vimodrone,  IT 20090
Correspondent Contact Maurizio Bianchi
Regulation Number878.4400
Classification Product Code
PBX  
Subsequent Product Code
NGX  
Date Received02/13/2020
Decision Date 08/11/2020
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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