Effective Date: August 13, 2026 Last Updated: August 13, 2026
Phreno makes a helmet-mounted sensor that records head impact data and an app that shows you what it recorded. It is a monitoring and awareness instrument. This page states plainly what that does and does not mean, because it is the most important thing to be clear about on a product related to head injury.
Short versions of this statement appear elsewhere on this site and in the app. Where any of them is briefer than this page, this page is the full statement.
Not a medical device
Phreno is not a medical device. It has not been cleared, approved, or authorized by the U.S. Food and Drug Administration or by any other regulator, and it is not intended to diagnose, treat, cure, mitigate, or prevent any disease or condition.
Not a diagnosis
A reading from Phreno is not a concussion assessment and not a diagnosis.
Phreno will not tell you whether you have a concussion. Nothing worn on a helmet can. Concussion is diagnosed by a qualified clinician, using symptoms, history, and examination. Many of those symptoms are subjective and invisible to any sensor. A number describes the forces the device measured. It does not describe what happened inside your head.
What Phreno gives you is objective context for a decision you were going to make anyway, and something concrete to hand to a doctor.
We are not clinicians
Nothing on this website, in the Phreno app, in our emails, or from our support team is medical advice. No Phreno employee or representative is offering a professional medical opinion, and no interaction with us creates a clinician relationship. If you have a health concern, consult a qualified medical professional.
Not protective equipment
Phreno is not personal protective equipment. It does not protect you against injury, absorb impact, or reduce the forces reaching your head. It does not replace a helmet, a hard hat, or any other protective gear, and wearing it does not make any activity safer than it would otherwise be.
Mounting hardware to a helmet or hard hat shell can affect that shell's certification. Follow the guidance of your helmet or hard hat manufacturer when fitting the sensor. On a jobsite, follow your site's rules on what may be attached to certified head protection.
It does not clear anyone to return to play or work
Phreno does not decide whether an athlete returns to play or whether a worker returns to a task. That call belongs to a qualified professional, working within your program's medical protocols or your site's incident procedures. Do not use a Phreno reading, or the absence of one, as the basis for that decision.
Accuracy and limits
Phreno measures what it measures, and no measurement is perfect.
- Readings depend on correct mounting, a charged and functioning device, and the sensor being on the helmet actually involved in the impact.
- The device can miss impacts, record them inaccurately, or fail outright.
- The absence of an alert is not the absence of injury. People are injured in events a sensor does not flag, and significant symptoms can follow impacts that measured unremarkably.
- Data may be delayed, incomplete, or lost, including when the device is offline or out of battery.
Never treat a quiet device as confirmation that you are fine.
If someone is hurt, act on that
If you or someone else has symptoms after an impact, stop the activity and seek medical care. Do not wait for the app, do not go looking for a reading, and do not let a low number talk you out of it. Symptoms matter more than data.
If symptoms are severe or worsening, including loss of consciousness, repeated vomiting, seizure, weakness or numbness, slurred speech, or worsening confusion, treat it as an emergency and call your local emergency number.
How this relates to our other terms
This Disclaimer sits alongside our Terms & Conditions and Privacy Policy. The Terms govern your use of the products and services, including limitations of liability, and the Privacy Policy governs personal information.
Shorter disclaimers appear on individual pages of this site, including the pages for teams and programs and for construction crews. Those remain accurate and apply in their context. Where a shorter note and this page differ in detail, read this page as the fuller statement, and read nothing here as narrowing the Terms.
Questions
If anything here is unclear, or you want to know what the product does before relying on it, email us at admin@getphreno.com. We would rather answer the question than have you assume.