LD TECHNOLOGY - We are Listening to the body Signals!

EIS-BF

>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*

FDA Registrations and Listing

>Indications / Intended uses
Records of electrical signals of 22 segments of the human body.
The electrical signals are related with patient's physiological parameters (autonomic system responses following the sending of a tension of 1.28 V), so that the patient can control voluntarily these physiological parameters (by stress reduction).

*Note: Class II Devices The Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act.