FDA.reportPublic FDA data

Mind Media Europe B.V.

GUDID#

NeXus Q24 - The NeXus Q24 is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG). The product is intended to be used by medical/access professionals in a laboratory setup or medical office, or to be set-up in such an environment after which the subject/patient can be sent out while signal acquisition continues on memory. The NeXus Q24 is not intended for use in diagnosis, nor in critical and/or life supporting applications.The NeXus Q24 is intended for use on humans.The NeXus Q24 is intended to be used with approved NeXus accessories only. Specifically, (active) sensors intended to measure specific physiological signals, shall be designed in accordance with the specifications of the NeXus.

Mind Media Europe B.V.

2025-12-03

NeXus 10 MK3 - The NeXus 10 MK3 is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG). The product is intended to be used by medical/access professionals in a laboratory setup or medical office, or to be set-up in such an environment after which the subject/patient can be sent out while signal acquisition continues on memory. The NeXus 10 MK3 is not intended for use in diagnosis, nor in critical and/or life supporting applications.The NeXus 10 MK3 is intended for use on humans.The NeXus 10 MK3 is intended to be used with approved NeXus 10 accessories only. Specifically, (active) sensors intended to measure specific physiological signals, shall be designed in accordance with the specifications of the NeXus 10 and may require interpretation by user or application software.

Mind Media Europe B.V.

2025-09-10

NeXus-10 MKII - The NeXus-10 MKII is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG). The product is intended to be used by medical/acces professionals in a laboratory setup or medical office, or to be set-up in such an environment after which the subject/patient can be sent out while signal acquisition continues on memory. The NeXus 10 MKII is not intended for use in diagnosis, nor in critical and/or life supporting applications.The NeXus 10 MKII is intended for use on humans.The NeXus 10 MKII is intended to be used with approved NeXus 10 MKII accessories only. Specifically, (active) sensors intended to measure specific physiological signals, shall be designed in accordance with the specifications of the NeXus-10 MKII and may require interpretation by user or application software.

Mind Media Europe B.V.

2021-08-13

Temperature Sensor (NB-TMP) - NB-TMP:The temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connected to a NeXus signal acquisition device. The sensor shall be placed on intact skin to provide a signal that is influenced by cutaneous blood flow. The sensor is not intended to determine directly or indirectly a measure of core body temperature and to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.

Mind Media Europe B.V.

2021-07-19

GSR-TMP Combination Sensor (NC-C-GT) - NC-C-GT:The GSR sensor provides a measure of skin resistance or skin conductance when connected to a NeXus signal acquisition device, which is influenced by the autonomic activation of sweat glands in the skin. The sensor output is not intended to be used for vital monitoring purposes.The temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connected to a NeXus signal acquisition device. The sensor shall be placed on intact skin to provide a signal that is influenced by cutaneous blood flow. The sensor is not intended to determine directly or indirectly a measure of core body temperature and to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.

Mind Media Europe B.V.

2021-07-19

Blood Volume Pulse Sensor (NB-BVP-F) - NB-BVP-F (finger module):The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.

Mind Media Europe B.V.

2021-07-19

Blood Volume Pulse Sensor (NB-BVP-H) - NB-BVP-H (head module):The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.

Mind Media Europe B.V.

2021-07-19

Blood Volume Pulse Sensor (NC-BVP-F) - NC-BVP-F (finger module):The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.

Mind Media Europe B.V.

2021-07-19

Blood Volume Pulse Sensor (NC-BVP-H) - NC-BVP-H (head module):The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.

Mind Media Europe B.V.

2021-07-19

Galvanic Skin Response Sensor (NB-GSR) - NB-GSR:The GSR sensor provides a measure of skin resistance or skin conductance when connected to a NeXus signal acquisition device, which is influenced by the autonomic activation of sweat glands in the skin. The sensor output is not intended to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.

Mind Media Europe B.V.

2021-07-19

NeXus Software - The NeXus software is intended to provide (near) real-time biofeedback and neurofeedback in the form of information, visual and auditory signals, corresponding to the state of one or more physiological parameters, so that a patient can learn voluntary control of these parameters. The software shall be used on a personal computer (in a medical office environment) in combination with compatible signal acquisition devices and sensor accessories to perform its intended use. The software is designed for medical use, not restricted to a specific medical indication. It is intended to be used within a medical office environment by, or under supervision of, a health professional (novice user, technical knowledge, normal eyesight, possibly achieved with the aid of glasses). The software is not intended for use in a life support application nor is it intended for diagnostic purposes.

Mind Media Europe B.V.

2021-07-19