The Apollo Neuro wearable is a consumer wellness device and does not require FDA approval for sale.
The Apollo Neuro wearable is intended to help manage stress, challenging life transitions, and to promote a healthy lifestyle. Apollo Neuro is not intended to treat or cure any medical conditions and is not a substitute for professional medical care.
These statements have not been evaluated by the United States Food and Drug Administration [FDA]. Individual results vary. Speak to your doctor if you have questions and to discuss solutions that may be appropriate for you.
The Apollo Neuro wearable has been built under design controls necessary for submission to the FDA. In addition, our manufacturer meets the Quality System Regulation ISO 13485 manufacturing requirements for medical devices sold in the United States.