The team at Sana Health, Inc. is pleased to confirm that the FDA has ratified Sana as a ‘Device of General Wellness’ through their 513(g) process in late June. We’re grateful and excited to have achieved this milestone on the journey to FDA approval for Sana.
What this means:
Sana is formally on the market as a safe and effective wellness device to enhance relaxation and improve well-being in healthy adults
Sana is officially considered a low-risk device
What’s next:
We are now transitioning our conversations with the FDA to focus on efficacy in particular areas, notably relief of fibromyalgia symptoms. We anticipate a submission to the FDA for approval for that indication sometime in the first quarter of 2021. The Sana device is not yet approved by the FDA for any clinical applications, but we are working on it.
Questions? Feel free to reach out to us anytime via email at support@sana.io; via phone at 720-310-3370; or chat with us on our website: www.sana.io. Our Customer Support Team is available 7 days a week to answer your questions and support you in your wellness journey.
