LD TECHNOLOGY - We are Listening to the body Signals!

EIS-BF

Only in US market

>Description of the features
*PART 882 -- NEUROLOGICAL DEVICES

•Devices Sec. 882.5050 Biofeedback device.

•(a)Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters ,so that the patient can control voluntarily these physiological parameters.

b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to 882.9.

FDA Registrations and Listing

>Feature
Records of electrical signals of 22 segments or pathways of the human body.
Sending of weak current very low frequency ( stimulation) to the 22 segments or pathways of the human body
The electrical signals are related with patient's physiological parameters (sympathetic and parasympathetic systems activity), so that the patient can control voluntarily these physiological parameters (relaxation training).

>Indications / Intended uses
Biofeedback device for training relaxation
The device is intended for use on healthy subjects
The device cannot be used for any diagnosis
The device will be used for children (over 5 years old) and adult patients.
The device is not intended for use in continuous monitoring.
The system will be used by practitioners.

WARNING : The EIS-BF shall be powered by the laptop battery with USB port interface.
Therefore, Only a laptop not connect to the 120V can be use when you are running the EIS-BF device.