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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
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