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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(k) Number K202788
Device Name Sonomed IV, Sonomed V
Applicant
Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto
R. Padre Machado, 82
Sao Paulo,  BR 04127
Applicant Contact Orlando Orlandi
Correspondent
Pr Servicos Regulatorios Administrativos Ltda
Rua Alice Aem Saadi, 855/ 2404
Ribeirao Pret,  BR 14096-570
Correspondent Contact Bruno Milhoci
Regulation Number890.5300
Classification Product Code
IMI  
Date Received09/22/2020
Decision Date 12/23/2021
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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