Australia - English - Department of Health (Therapeutic Goods Administration)

aimedical international pty ltd - 17929 - analyser, physiologic, neuromuscular function - luna emg is a multi-functional upper and lower limb soft-robotic rehabilitation robot for neurological and orthopaedic patients, it can perform force or emg driven exercises with the patient, entertain them with games and perform complex diagnostic tests to help provide objective data driven evaluations.luna emg uses reactive electromyography to train the sensorimotor cortex. the patient?s movement is active - based on bio-electrical signals (emg) acquired from the patient?s muscles. it is especially effective with clinical weakness patients, allowing 10x more motor unit recruitment during muscle flexion than manual treatment. due to luna?s personalised and automatic training programs, patients are engaged, and the therapist does less physical labour. with training reports created on the go the therapist can focus on the patient?s recovery instead of working manually.

Australia - English - Department of Health (Therapeutic Goods Administration)

aimedical international pty ltd - 56641 - stereotactic neuronavigation/planning system - the neural navigator is a certified medical device that can accurately target brain regions with millimetre precision indicated on an individual mri scan with transcranial magnetic stimulation (tms) coils. the neural navigator makes tms coil placement much more precise. with mri navigated tms, less participants in research projects are required for significant results, and tms treatments are much more efficient and achieve higher benefits for the patient.

Australia - English - Department of Health (Therapeutic Goods Administration)

aimedical international pty ltd - 61124 - transcranial magnetic stimulation system, mobile - the device is a magnetic stimulator intended for non-invasive stimulation of neuromuscular tissue; brain, peripheral nervous system and spinal cord by electromagnetic pulses: inducing small currents in the tissue using a brief pulse of electromagnetic energy and responses can be recorded with eeg/emg for further evaluation.

Australia - English - Department of Health (Therapeutic Goods Administration)

aimedical international pty ltd - 35747 - audiometer, auditory evoked response - the neuro-audio system is intended for use in electrophysiological and audiologic evaluation of hearing and vestibular function as an aid in detecting hearing loss and diagnosing hearing and vestibular related disorders. it can be used for screening and diagnostic applications. it allows recording auditory brainstem response (abr) and other auditory evoked potentials (aep), otoacoustic emissions (oae) and screening pure tone audiometry (pta). neuro-audio bone conduction amplifier unit is intended to record bone conduction vemps. the target population for neuro-audio includes all ages.

Australia - English - Department of Health (Therapeutic Goods Administration)

aimedical international pty ltd - 11474 - electromyograph - the litebox digital system is intended for the acquisition, display, analysis, storage and reporting of electrophysiological information from the human nervous and muscular systems, spinal cord, brain and heart.

Australia - English - Department of Health (Therapeutic Goods Administration)

aimedical international pty ltd -

Australia - English - Department of Health (Therapeutic Goods Administration)

aimedical international pty ltd - 61160 - magnetic neural stimulation system, stationary - to stimulate the central or peripheral nervous system by using magnetic stimulation, either by application to the cerebral cortex or peripheral nervous system

Australia - English - Department of Health (Therapeutic Goods Administration)

aimedical international pty ltd - 35757 - analyser, gait - the gait trainer is intended for objective assessment of gait function and rehabilitation of patients with gait disorders associated with locomotion system, peripheral nervous system, central nervous system and somatic symptoms. the gait trainer ensures rehabilitation using biological feedback (bfb) method and allows monitoring of rehabilitation dynamics through the data obtained with imu (inertial measurement unit) sensors. the systems can be used in different health care facilities (including clinics, hospitals, health centres, ambulance centres, etc.), specialised medical facilities (including prevention centres, medical centres for emergency, military and medical expertise centres), research and educational medical and biological facilities.

Australia - English - Department of Health (Therapeutic Goods Administration)

aimedical international pty ltd - 11467 - electroencephalograph - neuron-spectrum are stationary and ambulatory digital eeg systems & are intended to perform clinical electroencephalography (eeg), video eeg, long-term monitoring (ltm), polysomnography (psg), cardiorespiratory monitoring and galvanic skin response (gsr) testing. additional intended use for the stationary systems include multimodality long-latency (including cognitive), middle-latency and short-latency evoked potential (ep) testing, emg (including needle and surface emg) testing, nerve conduction studies (ncs), electo-oculography (eog) testing, biological feedback (bfb) testing. the ambulatory system is not intended to allow direct diagnostics or monitoring of vital physiological processes, where the nature of variations could result in immediate danger to the patient for instance variations in cardiac performance, respiration, activity of central nervous system. to perform ep tests, the patient can be stimulated with built-in auditory, photic and pattern stimulators and optionally supplied high-resolution pattern-stimulator, and can be used with accessories such as neuro-mep auditory-visual stimulator, neuro-mep electrical stimulator control unit plugged in the same usb controller and third-party stimulators connected via electronic unit trig-in/out. the system can be used for the recording of physiological signals obtained in response to magnetic stimulation of central and peripheral nervous structures with magnetic stimulator and also for measurement of oxygen saturation level (spo2). all the obtained data are recorded, displayed, analysed, stored and printed. the system is intended to be used by trained operators under direct supervision of a licensed health care practitioner in adult and pediatric patients. the systems can be used in patients of all ages.

Australia - English - Department of Health (Therapeutic Goods Administration)

aimedical international pty ltd - 35757 - analyser, gait - the qualisys clinical system is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. it is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics. the movement analysis report can be one part of the treatment assessment and no treatment decision shall be based on the movement analysis report as stand-alone data. the product is intended for professional use only, and is to be used by qualified professionals, trained in the use of the system.