BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)

    K Number: K241518 · Decision Aug 30, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    65
    Applicant Total
    3
    Review Days
    93

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    Basic Information

    Device Name
    Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)
    K Number
    K241518
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5805
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Magstim Company Limited
    Date Received
    May 29, 2024
    Decision Date
    August 30, 2024
    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 The Magstim Company Limited

    K Number Device Name
    K250286 Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)
    K243869 Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)