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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 K202148
Device Name E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)
Fit-Pro Ltd.
7 Szabadsag Ter
Budapest,  HU 1054
Applicant Contact Janos Papp
Fit-Pro Ltd.
7 Szabadsag Ter
Budapest,  HU 1054
Correspondent Contact Janos Papp
Regulation Number890.5850
Classification Product Code
Date Received08/03/2020
Decision Date 08/25/2021
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