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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K251958
Device Name VEINOPLUS Back
Applicant
Dynapulse Medical
13500 Wayzata Blvd.
Minnetonka,  MN  55305
Applicant Contact Steffen Magnell
Correspondent
MRC Global
9085 E. Mineral Cir., Suite 110
Centennial,,  CO  80112
Correspondent Contact Danielle Besal
Regulation Number882.5890
Classification Product Code
NUH  
Date Received06/25/2025
Decision Date 12/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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