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510(k) Data Aggregation

    K Number
    K220625
    Device Name
    ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
    Manufacturer
    Date Cleared
    2022-04-06

    (34 days)

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

    REMED Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ALTMS Magnetic Stimulation Therapy System (also Blossom TMS Therapy System) is indicated for the treatment of Major Depressive Disorder in adult patients, who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
    Device Description
    The ALTMS Magnetic Stimulation Therapy System (also Blossom TMS Therapy System) is a computerized, electromechanical medical device that generates and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation.
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    K Number
    K202537
    Device Name
    ALTMS Magnetic Stimulation Therapy System
    Manufacturer
    Date Cleared
    2021-11-26

    (451 days)

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

    REMED Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ALTMS Magnetic Stimulation Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients, who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
    Device Description
    The ALTMS Magnetic Stimulation Therapy System is a computerized, electromechanical medical device that generates and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation. The ALTMS Magnetic Stimulation Therapy System is an integrated system consisting of a combination of hardware, software, and accessories. It includes a Mobile console which houses the electronic components, provides mechanical support for the ferromagnetic Treatment Coil. The Standing Arm, an accessory device included in the ALTMS provides the coil positioning function.
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    K Number
    K202031
    Device Name
    Talent-Pro Electromagnetic Stimulator
    Manufacturer
    Date Cleared
    2021-05-06

    (288 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Remed Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Talent-Pro™ Electromagnetic Stimulator is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. The Talent-Pro™ Electromagnetic Stimulator is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes. Indications for Use for Muscle Stimulators: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion
    Device Description
    The Talent-Pro Electromagnetic Stimulator is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes, prevention or retardation of disuse atrophy. Talent-Pro Electromagnetic Stimulator consists of the Main body, Transducer for magnetic stimulation
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