A small, non-dedicated computer designed to be portable. It includes a microprocessor [central processing unit (CPU)], a display screen, and a keyboard integrated into one unit. It includes batteries for mobile use, and uses mains electricity (AC-power) for...
An application software program intended to be used in the management of an implantable cardiac device (e.g., monitor, pulse generator, pacemaker, defibrillator) by enabling computer-assisted functionality typically in one or more of the following areas: de...
An individual software program or group of programs, routines or algorithms intended to add specific computer assisted display, processing and/or analysis capabilities to a laser for storing, processing, and managing electronic information/data used during ...
A software program intended to assist with the evaluation of a patient’s hearing capability and/or hearing assistive devices. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and usually runs on an off-the-s...
A software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the h...
A battery-powered, hand-held, electronic instrument designed to measure the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] and forced expiratory volume (FEV) from the lungs. It typically includes a mouth...
An electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expirator...
An external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, an implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). It includes a radio-freque...
An application software program intended to facilitate dental treatment, which may include dental implant and/or oral/maxillofacial surgery planning, by storing/displaying patient demographics/clinical data and treatment plans, and may control settings for ...
A software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the h...
An external device intended to enable a layperson to noninvasively extract data from an implanted cardiac pulse generator (i.e., therapeutic active cardiac implant) to provide historic and/or current information on device performance, and may in addition be...
A software program intended to be used to assess cognitive function (e.g., attention/concentration, memory) and/or to assist early detection/diagnosis of mild cognitive impairment or dementia, using cognitive tests in combination with patient demographic da...
A hand-held device intended to enable clear view of the trachea via video imaging to facilitate positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation, passing the ET tube through an integrated ET tube ch...
A battery-powered device intended to be worn against the sole of the foot to sense, measure, and transmit information regarding plantar pressure distribution for the biomechanical analysis of gait. It is typically a synthetic insole with integrated pressure...
A portable, non-dedicated, and commonly hand-held computing device intended for the download/running of medical software to input, process and/or display data. It typically includes a microprocessor [central processing unit (CPU)], a display screen, and a k...
A software program intended to be used with an off-the-shelf computer/tablet/smartphone to help improve a cognitive function (e.g., attention/concentration, memory, eye movement training to improve reading ability) by providing a patient with on-screen inte...
A software program intended to be used with an off-the-shelf computer/tablet/smartphone to help improve a cognitive function (e.g., attention/concentration, memory, eye movement training to improve reading ability) by providing a patient with on-screen inte...
A hand-held, electrically-powered device designed to be operated by a clinician or patient to non-invasively change the settings (e.g., turn on/off) of an implantable cardiac monitor (ICM), and/or extract data from the implant, and/or provide an alarm funct...
A software program intended to wirelessly receive data from a noninvasive, patient-worn, wireless monitor/sensor to display, record, and assist in analysis and healthcare provider reporting reporting of the collected clinical data, typically for continuous ...
A software program intended to be used by a layperson at home to receive data from a noninvasive, patient-worn, wireless monitor/sensor to display, record, and assist in analysis and healthcare provider reporting of the collected clinical data, typically fo...
An external device intended to enable a healthcare professional in a clinical setting to noninvasively extract data from an implanted cardiac pulse generator (i.e., therapeutic active cardiac implant) to obtain historic and/or current information on device ...
An application software program intended to be used for estimation of the quantity of external blood loss during a surgical procedure by analysis of images of blood-laden absorptive devices (e.g., swabs) and suction canisters. It is intended to run on an of...
A software program intended to be installed on an off-the-shelf, computerized device (e.g., desktop computer, tablet) and used by a healthcare professional in a clinical/care setting to receive data from a noninvasive, patient-worn, wireless monitor/sensor....
An electrically-powered device intended to be used in a clinical setting and in the home to measure the concentration of exhaled carbon dioxide (CO2) in normal tidal breathing, using a particular method (e.g., infrared spectroscopy, gas chromatography), and...
An electrically-powered device intended to be used in a clinical setting and in the home to measure the concentration of exhaled carbon dioxide (CO2) in normal tidal breathing, using a particular method (e.g., infrared spectroscopy, gas chromatography), and...
A software program intended to be used by a patient whose neuromuscular abilities have been impaired by a disease/condition (e.g., Parkinson’s, stroke, traumatic brain injury) to help train and regain neuromuscular control (e.g., balance, strength, speech) ...
An application software program intended to be installed on a non-medical off-the-shelf device (e.g., computer/smartphone/tablet) to allow a healthcare professional to view real-time and historical patient physiologic data [e.g., electrocardiogram (ECG), bl...
A software program intended to be used with an off-the-shelf computer/tablet for the intraoperative analysis of electrophysiological data (e.g., impedance, neural response) collected from the electrode array assembly of a cochlear implant system during impl...
An electrically-powered device designed to automatically dispense the correct dose of an individual patient’s medication pills at specified times. It is typically a computerized, programmable, tabletop unit loaded with the patient’s pills; the pills are not...
A software program intended to help a patient regain functional physical and/or neuromuscular control through guided activities (e.g., physiotherapy exercises, visuomotor stimulating onscreen patterns, interactive games, speech exercises), in cases of muscu...