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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K201239
Device Name NuEra Tight Family, EMS Model
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 Number890.5850
Classification Product Code
NGX  
Date Received05/07/2020
Decision Date 12/31/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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