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Prism is a neurofeedback software device intended for relaxation and stress reduction through the use of EEG biofeedback. The device is indicated as an adjunctive treatment of symptoms associated with posttraumatic stress disorder (PTSD), to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions.

Prism is a software as medical device, to be prescribed for treatment of patients with PTSD by clinicians as adjunct to standard of care. Prism is a software device running on a laptop that uses EEG signal input from an EEG device (g.Nautilos PRO (K171669)). Prism therapy consists of 15, 30-minute sessions and optional periodic refresher sessions. During a session, the patient is connected to 8 or more EEG channels and views an interactive audio/visual interface.

Freespira is intended for use as a relaxation treatment for the reduction of stress by leading the user through guided and monitored breathing exercises. The device is indicated as an adjunctive treatment of symptoms associated with panic disorder (PD) and/or posttraumatic stress disorder (PTSD), to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions.

Freespira® is intended for use as a relaxation treatment for the reduction of stress by leading the user through guided and monitored breathing exercises. The device is indicated as an adjunctive treatment of symptoms associated with panic disorder (PD) and/or posttraumatic stress disorder (PTSD), to be used under the direction of a healthcare professional, together with other pharmacological and/or nonpharmacological interventions. Freespira is authorized and overseen by a licensed healthcare provider. Patients are trained to use the Freespira Sensor and the Freespira Mobile App to measure and display their exhaled carbon dioxide (EtCO₂) level and respiration rate (RR) and how different breathing habits affect EtCO2 levels.

The GrindCare System is indicated to aid in the evaluation and management of sleep bruxism by reducing the temporalis muscle EMG activity during sleep.

The GrindCare System is a portable electromyographic (EMG), electrical stimulation, and biofeedback device. It consists of a Sensor that is adhered to the skin over the temporalis muscle by means of an adhesive, disposable, single-use GelPad. The System also includes a Docking Station, USB Cable, and Power Adaptor. The Sensor and Docking Station record and store EMG activity data, which is transferred from the Docking Station to the GrindCare Mobile App, which allows the user to review grinding and stimulation data and enter diary notes. The Sensor uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events. In response to the EMG-measured contraction, it delivers mild electrical stimulation that is intended to relax the muscle and inhibit the bruxing event.

The Pacifier Activated Lullaby (PAL®) encourages and reinforces effective non-nutritive sucking of premature infants. This is accomplished by giving positive feedback to the infant in the form of music or a mother's voice as auditory input in direct response to sucking.

The Pacifier Activated Lullaby ("PAL®") has a player module, pacifier sensor module and power supply. The pacifier sensor module senses the strength and duration of an infant's sucking on an attached pacifier and responds with music or a recorded sound (i.e. mother's voice) contingent to the infant's sucking. The pacifier module consists of a wired transmitter with a built in pressure transducer that connects to the pacifier and a receiver. The receiver decodes the signal and plays music or a recorded sound for a predetermined length of time via a speaker to the infant contingent on his/her sucking on the pacifier transmitter. This action occurs when the sucking strength and duration exceeds preset values. The user can control the sensitivity of the transducer. This application describes modifications to the FDA cleared K010388 P.A.L. System.

NFANT® Feeding Solution is intended to measure movement of the nipple during non-nutritive suck (NNS) or nutritive suck (NS).

NFANT® Feeding Solution is comprised of a portable multi-use electronics unit (NFANT SSB Sensor) powered by a non-rechargeable coin cell battery, single use bottle coupling (NFANT Coupling) and mobile application which acts as a user interface and data display (NFANT App). Nipple movement data during Non-Nutritive Suck or Nutritive Suck is transmitted to a mobile device and displayed for clinician interpretation from past feedings can also be securely transferred, stored and retrieved by authorized users from a cloud based database (NFANT DBMS) for comparisons between feedings. When in use, the NFANT Coupling has a commercially available or prescribed bottle or pacifier nipple placed on one end and a normal bottle on the other. The NFANT SSB Sensor is snapped in place to mate with the NFANT Coupling. The user "wakes-up" (activates) NFANT SSB Sensor for streaming and data collection. An infant then undergoes normal nonnutritive sucking with a pacifier (no liquid swallow) and/or nutritive sucking with a bottle nipple during normal feeding sessions (liquid swallow). Nipple movement data is garnered and displayed on the mobile application for clinical interpretation. Safe oral feeding requires coordination of sucking, swallowing and breathing which involves integration, maturation and coordination of multiple sensorimotor systems. NFANT provides clinicians with objective data reqarding nipple movement during non-nutritive (NNS) and nutritive sucking (NS). As the infant sucks, the NFANT Coupling allows bottle fluid (when applicable) to flow from the bottle to the nipple. The NFANT Coupling maintains a plug insert that provides a two compartment membrane sealing the NFANT Coupling and separating the bottle fluid from pressure sensors contained in the NFANT SSB Sensor housing. With assembly, ports on the NFANT SNAP housing engage each respective membrane creating a seal between the NFANT SSB Sensor and NFANT Coupling while also creating two sealed chambers between the membrane and a respective pressure sensor. NFANT has one disposable component, the NFANT Coupling that comes in contact with the fluid. After a single use by a patient, the NFANT Coupling is disposed of in waste. The NFANT SSB Sensor does not come in contact with the feeding fluids and is reused specific to the infant with each NFANT Coupling usage. The NFANT App component is software only. NFANT is sold non-sterile.

The Canary Breathing" System is intended for use as a relaxation treatment for the reduction of stress by leading the user through guided and monitored breathing exercises. The device is indicated as an adjunctive treatment of symptoms associated with panic disorder, to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions.

The CBS is a biofeedback device that provides the user with a series of tone-guided breathing exercises and an awareness of his or her physiological data. The CBS uses standard biofeedback concepts to teach the patient to regulate their end-tidal CO2 (EtCO2) and respiratory rate (RR). The user's physiological data display allows the patient to see l ) the actual rate of their breathing and 2) how changes in breathing mechanics (depth and volume) affect EtCO2 levels. The CBS consists of a biofeedback training software program (mobile app) and an EtCO2 sensor (capnometer) used with a nasal cannula. The mobile app guides the user through an exercise and displays physiological data, while the sensor collects physiological data and feeds it to the mobile application for biofeedback. The patient's EtCO2 levels and RR are relaved from the capnometer to the mobile application via Bluetooth and are displayed on a tablet device, through the mobile application.

This device is to be used for general relaxation training when used with supported amplifier/encoders.

This software-only component of an EEG biofeedback system uses industry-accepted standard Microsoft Windows-based computers to accept EEG data from external FDAapproved amplifier/encoders and provide biofeedback information. The software does not provide any diagnostic conclusions nor provide any index, classification, diagnosis, or clinical interpretation of the data. The device processes EEG information, separates it into user-specified frequency bands, and displays the results as biofeedback indications to a user.

- For evaluation of the status of muscles at rest and in function - As an aid in muscle re-education and muscle relaxation therapy - Provides ability to compare new captured data with past data to assess progress in treating patients relaxation state

The device incorporates circuitry enabling the same capabilities as the predecessor device. It is a computer based system offering options capable of evaluating muscle groups at rest or in function by means of surface electromyography. Muscle activity is quantified by means of re-usable or disposable surface electrodes positioned over the muscle groups being studied. Up to eight sites can be monitored simultaneously and displayed in time or frequency domains. The device is essentially identical to the predecessor device except that it utilizes wireless (Bluetooth) technology to transfer EMG data to host computer without a cable and to eliminate any connection between the patient and line voltage.

The GRINDCARE device is indicated to aid in the evaluation and management of nocturnal bruxism by reducing the temporalis muscle EMG activity during sleep.

GRINDCARE is a portable electromyographic (EMG) and electrical stimulation device. The device consists of a stimulator, a docking station and a tri-polar electrode. The electrode is placed on the forehead with three integrated electrodes in close connection to the temporalis muscle by means of a double-adhesive patch incorporating three conductive gelpads and connected to the stimulator. The device records EMG activity and processes the signal to detect a particular activity (tooth grinding/clenching). It uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events. In response to the EMG-measured contraction, it delivers mild electrical stimulation that is intended to relax the muscle and inhibit the bruxing event. The EMG events are logged and stored on the device. This data can be transferred to a healthcare professional's PC for assessment of the user's bruxism.