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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 K230472
Device Name Sonopuls 190
Applicant
Enraf-Nonius, B.V.
127, Vareseweg
Rotterdam,  NL NL-3047AT
Applicant Contact Thomas Jozef Doodkorte
Correspondent
Quality and Regulatory Services
151 Gleasondale Rd.
Stow,  MA  01775
Correspondent Contact Scott Blood
Regulation Number890.5300
Classification Product Code
IMI  
Date Received02/22/2023
Decision Date 10/24/2023
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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