Search Filters

Search Results

Found 22 results

510(k) Data Aggregation

    K Number
    K234036
    Device Name
    SONIK MONARK 100
    Manufacturer
    Neuro Spinal Innovation Inc
    Date Cleared
    2024-02-15

    (56 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LXM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SONIK MONARK 100 device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the device to deliver precise impulses at a required vector configuration.
    Device Description
    The SONIK MONARK 100 (SM-100) device is used for the management of chronic pain due to noncongenital defects. It operates through the delivery of low-frequency impulses onto intact skin. The device converts electrical energy into mechanical energy, which is then transmitted to the patient's tissues through the stylus tip. It employs a mode of action that involves the application of controlled and repeatable low-intensity mechanical impulses to the treatment site. The device can be used in a handheld manner or mounted to a movable arm on a cart.
    Ask a Question
    K Number
    K192629
    Device Name
    Spinalytics
    Manufacturer
    Optima Health Solutions International Corp.
    Date Cleared
    2019-12-21

    (89 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LXM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KKT device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the patient. The procedure involves the use of diagnostic imaging that quantifies the misalignment of vertebrae. The treatment is then administered using the KKT device to deliver impulses at a precise vector. Spinalytics is a software application which facilitates treatment using the KKT device. Spinalytics provides an interface to manage the patient information stored in a central database. Spinalytics facilitates measuring angles and distances of relevant sketal structures in a patient, by providing the practitioner with an interface to mark the position of these structures directly on digitized X-Rays. Spinalytics then calculates standard treatment protocol parameters which can be sent directly to the KKT device. Spinalytics is an optional accessory to the KKT device and does not change the intended use of the device.
    Device Description
    Spinalytics Application is an optional software accessory to the KKT device which facilitates the calculation of the treatment parameters, which were previously calculated manually. Qualified personnel may generate, review, verify, approve, print and export the treatment plan prior to patient treatment. Spinalytics Application also communicates directly with the KKT Device to seamlessly enter the treatment parameters into the device. The clinicians may still enter their own parameters in the Spinalytics Application which meet their own treatment and clinical protocols, if they choose. The Spinalytics Application software is installed on a computer near the KKT Device. It can be installed on any commercial grade PC that meets the minimum hardware and operating system requirements. The computer and the KKT Device communicate over a USB cable.
    Ask a Question
    K Number
    K172536
    Device Name
    Atlas Percussion Adjusting Instrument
    Manufacturer
    Spinalight, Inc
    Date Cleared
    2018-06-20

    (302 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LXM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spinalight Atlas Percussion Instrument is to be used by a licensed Chiropractor to assist in making a Chiropractic adjustment to the atlas vertebrae. This adjustment is indicated when the doctor believes this bone to be out of alignment.
    Device Description
    The Percussion Adjusting Instrument is comprised of a Chiropractic Adjusting Table and a support system with a percussion device, which a Chiropractor positions over his patient to deliver an adjustment to the Atlas Vertebra (C-1). After the doctor positions the patient on the table, he aligns the instrument head so that the stationary stylus is positioned to the Atlas on predetermined vectors. Once this is completed the Chiropractor activates a solenoid contained within the adjusting head which strikes the proximal end of the stationary stylus generating a percussion wave through the stylus into the transverse process of the Atlas Vertebra. The objective is to produce a movement of the Atlas toward its proper alignment under the skull. Any time the patient is being positioned on the table or headpiece the percussion head is placed in the "Safe to Move" position.
    Ask a Question
    K Number
    K160278
    Device Name
    VSTAAR AdjusteR
    Manufacturer
    SPINAL ACOUSTICS, LLC
    Date Cleared
    2016-11-04

    (276 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LXM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VSTAAR is a mechanical device intended to be used by chiropractors, medical doctors and other licensed health care professions for the external analysis and adjustment of the human spinal column, and for soft tissue musculoskeletal mobilization.
    Device Description
    The VSTAAR AdjusteR is a mechanical device used by chiropractors, medical and other licensed health care professionals for the external analysis and adjustment of the human spinal column, and for soft tissue and musculoskeletal mobilization. The graphical user interface is mouse driven. All of the screens are easy to find and easy to understand. Navigating from screen to screen is quick and intuitive.
    Ask a Question
    K Number
    K130666
    Device Name
    KHAN KINETIC TREATMENT (KKT-M2)
    Manufacturer
    OPTIMA HEALTH SOLUTIONS INTERNATIONAL CORPORATION
    Date Cleared
    2014-01-23

    (317 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LXM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KKT-M2 device is to be used in the aid of management of chronic pain due to noncongenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the KKT-M2 device to deliver precise impulses at a required vector configuration.
    Device Description
    The KKT device has been developed for the aid in management of chronic pain. More specifically, conditions of chronic pain arising from structural anomalies such as misalianments and muscle imbalances. Conditions of brain stem irritation as a result of musculoskeletal imbalances that may arise from impact. Typical conditions treated include: strains to soft tissue surrounding vertebral column, whiplash injuries to the head and neck, and biomechanical disrelationships of the axial skeleton. This device is not intended to be used in acute situations of pain management. The KKT Device's mode of action consists of low-intensity mechanical impulses applied to the treatment site in a controlled and repeatable manner. The control of the direction (vector), amplitude and duration of the impulses allows for a known, finite, and predetermined amount of force and/or energy to be applied to the treatment site. This control is predetermined and then prescribed by a qualified medical practitioner where the treatment parameters to be correlated with (or derived from) data from X-rays, imaging systems, and physiological length, strength or distance measurements and used for the patient's treatment. The treatment protocol consists of a series of pulses applied to the atlas vertebra. Each pulse consists of a constant 16Hz frequency for approximately 750msec, a frequency sweep of 50 to 80 Hz in steps of 1 Hz for one full cycle each, followed by an extension while a twist is applied through the stepper motor, then a pause for approximately 750msec before the next pulse. The number of pulses can be set by the operator as can the amplitude of the stylus vertical motion and the amount and direction of the rotation. The device consists of a treatment head supported by an electrically actuated stand. Power is supplied through a grounded receptacle to an auto sensing 24VDC power supply. All actuators and controls are powered at 24VDC or lower. The vertical tower is positioned manually by sliding on the base plate and vertical and horizontal adjustment is controlled by redundant momentary switches located on either side of the horizontal arm. The position of the treatment head is set manually using the positioning display on the LCD screen mounted on the horizontal arm. Treatment parameters for duration and intensity are entered using the same screen or automatically through Client Application software. A release mechanism is incorporated into the treatment stylus to prevent excessive pressure being applied to the patient. This mechanism is interlocked through firmware to halt treatment and raise the treatment head when activated.
    Ask a Question
    K Number
    K112606
    Device Name
    ACTIVATOR V-E
    Manufacturer
    ACTIVATOR METHODS INTERNATIONAL LTD.
    Date Cleared
    2012-03-06

    (180 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LXM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Activator V-E is indicated for chiropractic adjustment of the spine and extremities. It is intended for external use only.
    Device Description
    Not Found
    Ask a Question
    K Number
    K082218
    Device Name
    MAX ADJUSTING INSTRUMENT
    Manufacturer
    MANNA OMNI INTERNATIONAL INC.
    Date Cleared
    2008-08-13

    (7 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LXM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MAX is indicated for chiropractic adjustment of the spine and/or extremities. MAX should be used by a licensed health care professional only. Intended for external use only.
    Device Description
    MAX is a hand-held chiropractic adjusting instrument that features automatic battery-powered operation instead of manual thrust. The electromechanical instrument uses a plunger-like mechanism to deliver thrust for chiropractic adjustment. The instrument is intended for use by a health care professional licensed by the law of the state in which he or she practices.
    Ask a Question
    K Number
    K080261
    Device Name
    IMPULSE IQ ADJUSTING INSTRUMENT
    Manufacturer
    NEUROMECHANICAL INNOVATIONS, LLC
    Date Cleared
    2008-04-11

    (70 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LXM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Impulse iQ Adjusting Instrument is intended for chiropractic adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine and/or extremities, or for soft-tissue musculoskeletal mobilization by a licensed health care professional only. For external use only.
    Device Description
    The Impulse iQ Adjusting Instrument is a hand-held electromechanical chiropractic adjusting instrument. The device has three force settings (low, medium, high), a preload-control indicator light that turns from red to green upon achieving the proper preload, and an internal accelerometer to provide closed-loop feedback controlling thrust pulse rate. The device is only intended for use from a health care professional licensed by the law of the state that he or she practices.
    Ask a Question
    K Number
    K072519
    Device Name
    ACTIVATOR V SPINAL ADJUSTING INSTRUMENT
    Manufacturer
    ACTIVATOR METHODS INTERNATIONAL, LTD.
    Date Cleared
    2007-10-23

    (46 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LXM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Activator V is indicated for chiropractic adjustment of the spine and extremities. It is intended for external use only.
    Device Description
    The Activator V is a hand-held electromechanical chiropractic adjusting instrument with a plunger-like mechanism that is intended to be used for chiropractic adjustment of the spine and extremities. The device is only intended to be used by a health care professional licensed by the state in which he or she practices. The thrust is provided by battery power rather than manual force. This makes it easier and less tiring for the chiropractor.
    Ask a Question
    K Number
    K060043
    Device Name
    KHAN KINETIC TREATMENT DEVICE (KKT-M1)
    Manufacturer
    OPTIMA HEALTH SOLUTIONS INTERNATIONAL, INC.
    Date Cleared
    2006-03-23

    (76 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LXM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KKT device is to be used in the aid of management of chronic pain due to non-congenital defects. The KKT device is to be used as part of a series of steps in the total care of the patient. The device is to be used for the treatment of vertebral motor units which appear to be fixated. The procedure can involve xray analysis that quantifies the lateral and rotational misalignments between the vertebrae. The treatment is then administered using the KKT device to deliver precise impulses at a required vector configuration.
    Device Description
    The KKT device provides an integrated treatment system unlike manual manipulation of the upper cervical spine, applying significantly smaller forces than those applied manually. While other handheld devices have been used which employ similar treatment methods, the KKT device provides significant advancement and improvement in moments, the ANT repeatability. The device consists of a display and controller, a force application probe, and a multi-axis adjustable stand. The device is used to apply force, rotation, and vibration to a patient.
    Ask a Question

    Page 1 of 3