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

aimedical international pty ltd - 11467 - electroencephalograph - neuron-spectrum digital eeg system intended for clinical electroencephalography (eeg), video eeg, long-term monitoring (ltm), polysomnography (psg), cardiorespiratory monitoring(crm), cerebral function monitoring(cfm), multimodality long-latency, middle latency and short latency evoked potential testing (ep), emg(needle and surface emg) testing, nerve conduction studies(ncs), biological feedback (bfb) testing, galvanic skin response (gsr) testing, heart rate variability(hrv) and cardiovascular reflex tests.

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

aimedical international pty ltd - 63313 - kinesiology/electromyographic sensor set - a collection of patient-worn devices consisting of both an electromyographic (emg) sensor and motion-based sensor intended to be used in a clinical setting as part of a system (e.g., virtual-display rehabilitation system, biomechanical analysis system) to provide non-gravity-compensating analysis, biofeedback, and/or interactive rehabilitation of neuromuscular/musculoskeletal conditions. it is typically intended to be used with a computer, interface devices, and software (not included).

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

aimedical international pty ltd - 47517 - arm rehabilitation system - esoglove is a device for hand rehabilitation with the intention to achieve recovery of hand function of indicated patients through passive and active-assisted hand mobilization.

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

aimedical international pty ltd - 17929 - analyser, physiologic, neuromuscular function - the wristmotus system is intended to enable individuals with wrist joint dysfunctions to improve the muscle strength, rom (range of motion), motor control, cognition and adl (activities of daily living). wristmotus is not intended for aggressive use.

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

aimedical international pty ltd - 17929 - analyser, physiologic, neuromuscular function - the anklemotus system is intended to enable individuals with ankle joint dysfunctions to improve the muscle strength, muscle tone, rom (range of motion), motor control, cognition and adl (activities of daily living). anklemotus is not intended for aggressive use.

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

aimedical international pty ltd - 58943 - ambulation exoskeleton, clinical - keeogo is a powered orthosis intended to provide mobility and stability assistance to the user. keeogo provides complementary knee strength and stability to assist ambulatory activities such as: ? walking gait ? sit-to-stand and stand-to-sit ? squatting, crouching, ? kneeling, and ? stair climbing (ascent and descent) keeogo is adjustable to fit the lower body of the patient and detects via sensors, the hip and knee movement of the patient. these data are used to detect the user?s gait characteristics and assist accordingly.

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

aimedical international pty ltd - 44358 - wrist/hand/finger flexion orthosis, electric - the intended use of handyrehab is a battery-powered robotic glove that is used for mobilizing users? fingers. it aims to reinforce the strength of the flexor and extensor of the user?s hand. with the aid of the handyrehab application, users can also facilitate their hand movement through specified training.

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

aimedical international pty ltd - 46566 - neurophysiologic monitoring system - neuro-iom system with neuro-iom.net software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient?s neurophysiological status. the system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways. it is provided in iii different configurations: i. 32/b ii. 32/s iii. 16/s the system ensures the following iom modalities: free-run emg (electromyography), direct nerve stimulation including pedicle screw test, ssep (somatosensory evoked potentials), mep (motor evoked potentials), eeg (electroencephalography), aep (auditory evoked potentials), vep (visual evoked potentials), direct cortical stimulation. also, the train-of-four (tof) stimulation is performed. the system is not intended to measure the vital signs. it records the data to be interpreted by the neuromonitoring specialist.

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

aimedical international pty ltd - 43114 - balance/mobility management system platform - the kine-sim is a versatile tool, enjoyable and attractive, that can challenge balance, gait, reflexes and endurance in multiple clinical situations and for many different age groups. the therapist is responsible for determining the appropriate treatment and clinical cases where the kine-sim best suits its professional practice and clientele. for example, the kine-sim can be used by fragile users or the ones that require more assistance. it is easy to use and allows the patients that present apraxia to perform activities and movement that they would not be able to achieve in real life context. the kine-sim also allows a level of customization that can increase the participation of users that present cognitive troubles.

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

numedical pty ltd - 47178 - hevea-latex surgical glove, non-powdered - hevea-latex surgical glove, non-powdered; a sterile device made of hevea natural rubber latex (nrl) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. the device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. it will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. this is a single-use device.