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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromagnetic Stimulator, Pain Relief
510(k) Number K230014
Device Name MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption
Applicant
Tonica Elektronik A/S
Lucernemarken 15
Farum,  DK DK-3520
Applicant Contact Jan Kjøller
Correspondent
MagVenture A/S
Lucernemarken 15
Farum,  DK DK-3520
Correspondent Contact Kirstine Klitgaard Schou
Regulation Number882.5890
Classification Product Code
QPL  
Subsequent Product Code
IPF  
Date Received01/03/2023
Decision Date 08/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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