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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 K200545
Device Name Legend Pro DMA
Applicant
Pollogen, Ltd
6 Kaufman Street
Tel Aviv,  IL 6801298
Applicant Contact Ayala Kamil
Correspondent
Benjamin L. England and Associates
810 Landmark Dr, Suite 126
Glen Burnie,  MD  21061
Correspondent Contact Amaya De Levie
Regulation Number890.5850
Classification Product Code
NGX  
Date Received03/03/2020
Decision Date 10/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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