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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
Bios s.r.l.
Via Guido Rossa 10/12
Vimodrone,  IT 20090
Applicant Contact Maurizio Bianchi
Bios s.r.l.
Via Guido Rossa 10/12
Vimodrone,  IT 20090
Correspondent Contact Maurizio Bianchi
Regulation Number878.4400
Classification Product Code
Subsequent Product Code
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