Innovative Measurement of Physiological Function
Is the technology cleared by the FDA as a medical device?
No. The device meets the criteria as a General Wellness Product as defined by the FDA, therefore negating the need for FDA clearance as a medical device. In January 2015, the FDA provided draft guidance titled: General Wellness: Policy for Low Risk Devices, Draft Guidance for Industry and Food and Drug Administration staff.
Is the technology a diagnostic device?
No. It is a “general wellness, low risk medical device” as defined by the FDA. Its measurements and reports provide objective, reproducible data/information that can be used to guide healthy lifestyle choices.
Who do I contact if I’m interested in performing a clinical trial using the EPIC technology?
Please complete the information on the Contact Us page and include a copy of your proposed clinical trial. A member of our team will be in touch with you to discuss the details.
Who do I contact if I’m interested in purchasing an EPIC system?
Please complete the form on the Contact Us page or call 480-477-5242 and ask to speak to Customer Service.
Are EPIC’s products sold outside of the US?
Currently, EPIC’s products are sold only in the USA.