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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
510(k) Number K210572
Device Name Neurodyn V2.0, Neurodyn Aussie V2.0
Applicant
Ibramed Equipamentos Medicos
Av. Dr. Carlos Burgos, 2800 - Jardim Itália
Amparo,  BR 13901-080
Applicant Contact Fabio Alexandre Pinto
Correspondent
United Regulatory, LLC
12343 NW 25th St.
Coral Springs,  FL  33065
Correspondent Contact Rodrigo Abreu
Regulation Number890.5850
Classification Product Code
IPF  
Date Received02/26/2021
Decision Date 05/11/2021
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
Predetermined Change
Control Plan Authorized		 No
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