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510(k) Data Aggregation

    K Number
    K243459
    Device Name
    Ultimate rTMS for OCD (M-series)
    Manufacturer
    Brain Ultimate, Inc.
    Date Cleared
    2025-04-17

    (160 days)

    Product Code
    QCI
    Regulation Number
    882.5802
    Why did this record match?
    Applicant Name (Manufacturer) :

    Brain Ultimate, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ultimate rTMS for OCD is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder(OCD).
    Device Description
    The Ultimate rTMS for OCD is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Obsessive-Compulsive Disorder (OCD). It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions. The Ultimate rTMS principle of operation is based on the discharge of high voltage capacitor through stimulation coil; the pulsed magnetic field generated by the discharge current penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons. Area of the brain to be simulated for ODC treatment is the Dorsomedial Prefrontal Cortex.
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    K Number
    K243460
    Device Name
    Ultimate rTMS
    Manufacturer
    Brain Ultimate, Inc.
    Date Cleared
    2025-04-17

    (160 days)

    Product Code
    OBP
    Regulation Number
    882.5805
    Why did this record match?
    Applicant Name (Manufacturer) :

    Brain Ultimate, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ultimate rTMS is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.
    Device Description
    The Ultimate rTMS is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Major Depressive Disorder. It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions. The Ultimate rTMS principle of operation is based on the discharge of high voltage capacitor through stimulation coil; the pulsed magnetic field generated by the discharge current penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons. Area of the brain to be simulated for MDD treatment is Left Dorsolateral Prefrontal Cortex.
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    K Number
    K230735
    Device Name
    Ultimate rTMS; Yingchi rTMS
    Manufacturer
    Brain Ultimate, Inc.
    Date Cleared
    2023-09-13

    (181 days)

    Product Code
    OBP
    Regulation Number
    882.5805
    Why did this record match?
    Applicant Name (Manufacturer) :

    Brain Ultimate, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ultimate rTMS is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
    Device Description
    The Ultimate rTMS is composed of stimulation generator and stimulation coil. The stimulation generator contains a high voltage energy storage capacitor charging and discharging system, an auxiliary power supply, a microcomputer control system, and a cooling system. The stimulation coil is composed of a stimulation coil, a cooling system, a data collection system, and a communication system. - Magnetic Stimulator - Cooling unit - Coils - Coil Figure-of-eight coil (BF90A) - Coil Figure-of-eight coil (BY90A) - Coil Figure-of-eight coil-With angle 120°(BY90B) - Trolley (optional) - Coil holder (optional) - PC (optional) - PC keyboard (optional)
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