The FDA website can be a little difficult to navigate so the following are screen captures with links to the FDA website. The Indigo device is manufactured by QWV. The registered establishment name is EPR Signature Solutions LLC.

FDA Biofeedback Medical Specialty Classification – Neurology

Here is the link to the Indigo Biofeedback Device Listing for QWV;

EPR SIGNATURE SOLUTIONS LLC Listing

EPR Indigo Device Registration Number

Another option to find the listing is to use the link below and you will see the search options.  Use the option to search by Company or Device.  In the field for Company, type the manufacturer name ‘Quantum World Vision’ and then click ‘Search’

FDA Device Listing Search

BIOFEEDBACK SYSTEMS ARE REGISTERED WITH THE FDA AS CLASS II EXEMPT DEVICES. 

For more information on this, please click on the links below revealing the direct information from the FDA’s website:

The first link indicates what a Class II Exempt device is:
Medical Devices Device Regulation and Guidance

The second link shows that biofeedback systems are classified as Class II Exempt and are listed under Neurological Devices Part 882. FDA Class II Exempt Neurological Devices

This third link shows that biofeedback systems are classed as Class II medical Exempt 510(K), under neurological, Part 882.5050 Class II Medical Exempt 510(K)