The FDA website can be a little difficult to navigate so this should help make it easier to find the location of the INDIGO Biofeedback System, manufactured by Quantum World Vision.
This link will take you to the part of the FDA’s website that gives access to Biofeedback devices;
Below is the link to the Quantum World Vision Listing (Note if this page location no longer shows the listing it is because other entries on the FDA’s website moved it to another page. Currently it is on Page 16, but you can find it alphabetically under the ‘Q’s for Quantum World Vision.
When you click on Quantum World Vision you will see;
When you click on the words ‘Indigo Biofeedback System’ it shows you the Establishment Registration and device listing;
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’
BIOFEEDBACK SYSTEMS ARE REGISTERED WITH THE FDA AS A CLASS II EXEMPT DEVICE.
For more information on this, please click on the 4 links below revealing the direct information from the FDA’s website:
The first link indicates what a Class II Exempt device is:
The second link shows that biofeedback systems are classified as Class II Exempt and are listed under Neurological Devices Part 882. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm
This third link shows that biofeedback systems are classed as Class II medical Exempt 510(K), under neurological, Part 882.5050 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm?GMPPart=882#start
The fourth and final link shows the listing for Biofeedback systems: