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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 K251083
Device Name Compact II
Applicant
Enraf-Nonius, B.V.
Vareseweg 127
Rotterdam,  NL 3047
Applicant Contact Lambert Luong
Correspondent
Qara Consulting, LLC
151 Gleasondale Rd.
Stow,  MA  01775
Correspondent Contact Scott Blood
Regulation Number890.5850
Classification Product Code
IPF  
Date Received04/09/2025
Decision Date 09/12/2025
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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