BREAKING NEWS!
The U.S. Food and Drug Administration (FDA) has approved the registration of the new INDIGO Biofeedback Device as an exempt Class II device!
(William Cunningham evaluating the new INDIGO Quantum Biofeedback Device)
An Establishment Registration with the FDA is required when selling a medical device in The USA. Quantum World Vision, as the manufacturer of the Indigo Biofeedback System, is the responsible party for safety and effectiveness of the Indigo device.
Quantum World Vision received their 2010 Establishment Registration listing with the FDA and received Owner/Operator Number 10031466. The Indigo Biofeedback System is a Class II Exempt device which means it does not require a 510(k) registration number.
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Medical Devices have different registration requirements for each country. The USA recently made the Class II Exempt status for biofeedback devices therefore making registration in The USA faster than other countries. For the rest of the world (including but not limited to Europe, Canada, South Africa, Australia, etc.) the registration application process for the Indigo is still in process.
For More Details, contact William J. Cunningham
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