BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    MagVenture Accelerated TMS (aTMS) Therapy System

    K Number: K260189 · Decision May 22, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    65
    Applicant Total
    18
    Review Days
    120

    Basic Information

    Device Name
    MagVenture Accelerated TMS (aTMS) Therapy System
    K Number
    K260189
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5805
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tonica Elektronik A/S
    Date Received
    January 22, 2026
    Decision Date
    May 22, 2026
    Product Code
    OBP
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OBP Transcranial Magnetic Stimulator

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    Other Clearances by Tonica Elektronik A/S

    K Number Device Name
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    K193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system
    K173620 Mag Vita TMS Therapy System w/Theta Burst Stimulation
    K172667 MagVita TMS Therapy w/MagPro R20
    K171967 MagVita TMS Therapy System
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