I saw a video today on YouTube of the Fourth Frontier X2 ECG Heart Rate Monitor. Is anyone using one? The data alone looks super interested, and I see they are 40% off on Amazon currently…
Link to video I saw:
I picked one up around 18 mos ago because I’m a physician and was having a strange heart arrhythmia only during specific extreme circumstances. Wanted to see what the rhythm was before I consulted a cardiologist or dropped dead during an interval session 
The only reason I can think of for someone to purchase this very expensive strap option is to record your rhythm if you suspect an arrhythmia. There are other ways to record your rhythm as well - ECG app on the Apple Watch or another very clever device called the Kardia. 2 advantages of the FF X2 - you don’t have to free your hands and you get a recording for as long as it’s needed. For the Apple Watch you need one hand free and for the Kardia you need both hands free. Also both the Kardia and the Apple Watch record for a limited time before automatically stopping.
Incidentally my rhythm is a re-entry tachycardia with aberrancy. I initially caught it with the Apple Watch while running and noticed it was a wide complex rhythm. I purchased the Kardia then later the FF to get a better telemetry tracing from actual chest sensors to help me figure out the actual tachyarrhythmia.
BTW, I figured out that my tachyarrythmia was brought on by a fairly hard effort with caffeine on board and usually sleep deprivation as well. Also the stress of a race lowered my threshold for arrhythmia. Put all 3 together and I can easily reproduce it.
@Powhoundus, helpful info. I’m curious, as a physician how do you think about the Fontier X2 not being FDA approved where the other options (including the Garmin Fenix 7 series and some others) being validated for ECG?
I do like the idea of ongoing monitoring vs trying to capture episodes.
Quick clarification….the FDA does not “approve” medical devices, they only issue a clearance to sell them via a 510(K). Even if you have the 510(k), it does mean it is “approved” by the FDA. It is an important distinction that most people are unaware of.
If FF does not have FDA clearance, then there should be limits on what claims they can make re: the functionality of the device. While I haven’t looked at their documents, my guess would be that there is a clause somewhere where it says sit is not for medical use and only for recreational / sporting activities.
Most pulse ox meters on the consumer market also use similar verbiage as very few are cleared for medical use.
If they are making medical claims about their device and they do not have a 510(k), that would be a bit worrying, IMO…but again, I have not read their literature or reviewed their marketing claims.
Very helpful distinction. I was probably a bit biased by DCRainmaker’s take on the medial clearance issues (ny GoogleFu is failing me and I can’t find his post to link here)… Yes, Fourth Frontier does say that it’s not a device for medical use.
edited: here’s the discussion from 2020, starts with post #26 in the comments.
Yeah, I discussed it somewhere else here too. However, I’m holding firm on this.
Fourth Frontier’s entire website homepage is virtually dedicated to using their product as an ECG device for “heart health”, with an extreme focus on monitoring, alerting, and 24x7 tracking.
In Fourth Frontier’s case, they have not gone through the FDA process for demonstrating their devices are “substantially equivalent” to existing FDA Approved devices (note from a technicality standpoint, these “substantially equivalent” approvals are known as 510(K)'s, as they have to demonstrate that they are equal to something on the legacy approved list). In any case, don’t misunderstand that 510K process to be minor, it’s a multi-year process with huge participant studies and all.
And ultimately, it’s for good reason: To protect consumers from crap devices that could kill someone.
It’s possible that Fourth Frontier makes a perfectly sound/accurate device. And yes, that process costs lots of money. But that’s the way it is, and trying to sell people on something that isn’t medically cleared, but implying heavily it is, it’s scammy.
Their homepage does not once mention it’s not a ‘Medical Device’, and if you click on the page titled ‘Regulatory and Safety’, they throw a ton of specs at you, implying it’s a medically certified device in a host of countries. When in reality, these certifications are literally just FCC approvals that they manage to not screw-up Bluetooth broadcasting, the same approvals that a cadence sensor has.
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Yeah, as I intimated above, if FF is making medical claims without obtaining 510(k) clearance, that is indeed worrying.
Now, there are all kinds of ways you can play “close to the edge” with your claims (and again, I have not reviewed their marketing materials), but I have to agree that this sounds kinda questionable.
Thanks for bringing your POV to this thread, Ray!
As an Emergency Physician that has used the FF, Kardia and Apple Watch I can honestly say the telemetry tracing is similar to the Kardia and Apple but in better resolution so I could actually make the diagnosisn (V Tach vs Re-entry tach with aberrancy). They look very similar on crude tracing Apple and in between Kardia. I would say though for most arrhythmias you could make the diagnosis with the Apple / Kardia as long as you can catch it with your hands free, as required by both of these devices. If you were someone who had a rarely occurring arrhythmia and just wanted to monitor your heart for a long time, the FF would definitely be the device for that.
Regarding the FDA approved status, I can honestly not see why it would matter for the FF. It gives you the rhythm and IMO it’s accurate, FDA approval or not. It’s not like it’s a drug you are ingesting - and lots of folks ingest lots of things every day as a “treatment” that is not FDA improved. Even in healthcare, we occasionally do a treatment that is not approved for a med but known to work. It’s called “off label” treatment in medicine.
Again, it is not FDA “approved”…no medical device is. It is FDA “cleared”. The importance of obtaining a 510(K) was explained upthread.
You cannot make medical claims about medical devices without a 510(K). This is done to protect users.
I get it. My slip up re: wording. Just wanted to point out that based on my experience with telemetry using real medical devices FF is absolutely accurate and currently the best you can buy regarding such devices - regardless of approval. But as I pointed out above, very few should need such accuracy and long term recording unless you have an arrhythmia that’s hard to catch otherwise.
Given I’m 5 weeks past a full sternotomy open-heart surgery to repair a dilated aortic root and replace my aortic valve this might be of great value to me going forward. I developed aFib a week post-surgery (which I’m learning is fairly common for 1/3 of open-chest surgery patients) which is now controlled with meds (and I’m on blood thinners for a several month course). I’ve also read/listened to a post by a cardiac surgeon at the Cleveland Clinic that aFib in 90% of the 30% resolved itself in 6 months regardless of intervention (meds, cardioversion or even no treatment) so I’m hoping to get weaned off my meds sooner rather than later. Having this type of EKG capture would help me work with my cardiologist to see if I have any further incidents of arrythmias and what they might be so we can keep me safe while still being able to go for it.
Edited: just read this fascinating article by Chuck Pena at Pez Cycling on his experience w/ aFib…
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I hate to belabor the point, but this really underlines the point I was trying to make….your experience is anecdotal. But when you are talking about a medical device, or making medical claims re: a device, that just isn’t good enough.
Obtaining a 510(k) requires clinical validations studies, etc. that demonstrate a device is accurate as it pertains to the medical claims you are making. It is not easy, cheap or frivolous to obtain FDA clearance……and that is generally a good thing (lord knows I have my frustrations with the FDA and 510(k)’s.)
And again, I think you are missing my point because you don’t seem to be an experienced clinician. My experience comes from thousands of EKG and telemetry tracings over my career. Again, this is not a supplement or drug you are ingesting. It’s not like a BP monitor where it needs to be tested on many different arms. Or an O2 saturation sensor that is subject to many variables. If the tracing is accurate compared to my known EKG it’s going to be accurate on anyone with a reasonably athletic body habitus. I don’t think we have many obese folks here, or folks with COPD, but those are groups that typically give the EKG machine a bit of a problem getting a good tracing and I wouldn’t make my claims for this device for those folks. If I’m using a new EKG machine I just need to see one EKG against a known tracing from another machine to know it’s 100% accurate.
A quick Google search led me to this statement: “ With data from the 200 companies that responded, the average total cost to get a Class II 510(k) product from concept to FDA clearance was $31 million dollars “ I honestly don’t blame a small company from delaying or ignoring that process. Maybe they are waiting until they make $31 million?
I stand by my recommendation and since this device really has no competition for “over the counter” hands free rhythm monitoring, you are left with getting one of those “FDA cleared” medical event monitors (and every one I’ve seen had stick on leads, useless for an athlete!) or this device. The cleared medical device will also require a doc to order it, and you better hope the cost is covered by insurance because it won’t be cheap. What alternative do you recommend?
Correct. I run a consumer medical device company that is very familiar with 510(k) regulations.
And there in lies the issue…you have no way of ensuring that the person using a FF has a “reasonably athletic body”….it is very possible that an obese person could use it, or any other body type.
This is why, if you are going to make medical claims about a device, you need to get FDA clearance through a 510(k)
I’m not certain what companies they are talking to, but I can assure that number is laughably wrong.
I do…it is the law and it is designed to protect consumers. You don’t get to ignore it simply because you don’t like it.
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