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510(k) Data Aggregation

    K Number
    K243775
    Device Name
    True Non-Surgical Spinal Decompression System (DRX9000-SL)
    Manufacturer
    Excite Medical of Tampa Bay, LLC
    Date Cleared
    2025-07-18

    (221 days)

    Product Code
    ITH
    Regulation Number
    890.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Excite Medical of Tampa Bay, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243366
    Device Name
    DRX9000C-SL Cervical Spinal Decompression System
    Manufacturer
    Excite Medical of Tampa Bay, LLC
    Date Cleared
    2025-06-18

    (233 days)

    Product Code
    ITH
    Regulation Number
    890.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Excite Medical of Tampa Bay, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DRX9000C-SL Cervical Spinal Decompression System provides a program of treatments for relief from pain for those patients suffering with neck pain. It is designed to apply spinal decompressive forces to the spine. Conditions that may be treated include neck pain associated with herniated discs, protruding intervertebral discs, degenerative disc disease, and posterior facet syndrome.
    Device Description
    The DRX9000C-SL Cervical Spinal Decompression System provides accurately controlled tensions designed to relax and confuse paraspinal muscles and allow distractive forces to decompress intervertebral spinal disc space. The user interface provided by the treatment computer constantly updates a servo-amplifier controlling a servo-motor to immediately and safely apply forces as determined by qualified healthcare personnel. Load-cell feedback is utilized to further verify and adjust tensile forces, allowing for variations in patient posture and outside forces such that continuous and smooth tension is experienced by the patient. A headpiece harness is used to help distribute the applied forces evenly. Once in place, the patient is slowly reclined to a horizontal position. Following the physician's orders, the therapist localizes the pain, makes any adjustments and directs the treatment to the proper area. The DRX9000C-SL Cervical Spinal Decompression System helps to mobilize the troubled disc segment without introducing further damage to the spine. The patient safety switch is held by the patient who at any time and for any reason may quickly pause any tensile forces. The patient safety switch is monitored and executed by two redundant systems, which will gradually reduce the tension to zero to stop the treatment and after a 5 second delay directly disable the treatment motor. The emergency stop button is accessible to the operator who at any time and for any reason may quickly pause any tensile forces. The emergency stop button is monitored and executed by two redundant systems, which will gradually reduce the tension to zero to stop the treatment and after a 5 second delay directly disable the treatment motor. Integral to effective spinal decompression and included in the device are continuous load-cell tensile feedback into the treatment computer, servo-amplifier and servo-motor, smoothly modulated cyclic tension application (high and low tension plateaus transitioned into via non-linear tension change), headpiece harness, patient safety switch, and mattress.
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