ZKTeco SpeedFace+ Are Medical Devices, Per FDA Definition, Contrary Claims Are False

By John Honovich and Charles Rollet, Published Jun 12, 2020, 07:23am EDT

ZKTeco SpeedFace+ series products are medical devices as defined by the US FDA. Contrary claims made by ZKTeco are false.

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In May, IPVM published Fever Cameras Are Medical Devices, Per The FDA, Dahua, Feevr, Hikvision, InVid Contrary Claims Are False. In response, a member questioned ZKTeco's positioning so we researched it.

ZKTeco's attorney objected to our questioning and reporting, calling this "a fine legal distinction that your [IPVM] audience would not understand."

Background: ZKTeco Claims

On June 5, 2020, ZKTeco CEO Larry Reed claimed on an IPVM comment that:

As far as ZKTeco is concerned, our SpeedFace+ series is not comprised of medical devices and we make no claims having any health related benefits. Therefore our SpeedFace+ is currently exempt from FDA compliance. If FDA informs us otherwise, we will do whatever is necessary to be compliant. [emphasis added]

ZKTeco's product FAQ similarily claimed:

ZKTeco devices which include body temperature detection are exempt from requiring FDA approval because SpeedFace+ Series models are not medical devices as defined by the U.S. Food & Drug Admin. ZKTeco makes no claims regarding health benefits derived by using our devices. They simply detect and record body temperature [emphasis added]

Note: the body temperature claims are false, these products detect skin temperature, not body.

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#feverdetection

ZKTeco's CEO markets this product as "#feverdetection", showing he clearly knows the intent of this product is medical:

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Reed deleted the above post after we notified him of our concerns.

However, in the past week, Reed continued to market 'installing body temp' for #feverdetection:

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UPDATE: Reed has now edited his post from the past week to remove the term "#feverdetection".

ZKTeco knows and shows they intend body temperature to be used for fever detection, a clear medical act.

Coronavirus Marketing

Moreover, ZKTeco's CEO is simultaneously promoting their body temp detection to reopen businesses shut down by coronavirus:

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Reed emphasizing here he knows that 'body temperature detection' is being used during the "COVID-19 scare":

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Sick Workers / Deny Access

Moreover, ZKTeco USA's webpage about "How can body-temperature help better safeguard employees?" declares:

When employees come to work sick, they put many people at risk. With the SpeedFace+ series readers, they can help detect when users have high body-temperature [emphasis added]

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Further showing ZKTeco intends this to be used to identify sick workers, contrary to their excuse that they "They simply detect and record body temperature".

Moreover, ZKTeco intends the device to be used to 'deny access' to people who have "unacceptable body-temperature" as their website demonstrates:

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Moreover, ZKTeco has designed the product to alert at 100.4°F, the CDC minimum temperature for fever, as this excerpt from their product FAQ shows:

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Plus, ZKTeco has designed the product with the intent to monitor for 'abnormal temperatures' that, consistent with the excerpt above, that they will use to deny users, as the FAQ excerpt below shows:

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The company from the beginning has intended this to be used to detect fevers as their March 2020 datasheet repeatedly declares:

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Update: ZKTeco has now deleted the March 2020 datasheet but we archived a copy of the ZKTeco 'fever' datasheet here.

FDA Says Fever Detectors Are Medical Devices

As IPVM has reported, devices used to detect elevated skin temperature are considered medical devices by the FDA. There is no such thing as a device intended for this purpose that is somehow not considered a medical device and thus, as Reed claims, "exempt from FDA compliance".

Reed writes that ZKTeco makes "no claims about having any health related benefits". But making health claims is not the main factor the FDA uses when determining whether a thermal imager is a medical device.

The key criterion is whether the device is "intended for a medical purpose" which includes skin temperature detection, the FDA wrote in recent guidance:

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Telethermographic systems are [medical] devices when they are intended for a medical purpose, such as measurement of the self-emanating infrared radiation that reveals the relative temperature variations of the surface of the body

Clearly, these ZKTeco products have the ultimate goal of finding potentially febrile individuals during a pandemic. This is a "medical purpose" regardless of what wording ZKTeco or its CEO uses.

ZKTeco Attorney Responds

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ZKTeco attorney Bradley Merrill Thompson of D.C. law firm Epstein Becker Green responded to IPVM, saying:

let me get this straight. You are alleging that the company's product is a medical device. You also know being a medical device is not a violation of the law. As you have reported yourself, medical devices in this category are allowed to be marketed during the pandemic. So your argument, if I understand it correctly, is that Larry Reed, who is not an attorney, is under an incorrect impression regarding the legal term to describe his product. That's it. No violation of law. Just a concern that a nonlawyer doesn't understand a legal term? You are arguing that he said his product is exempt as not a medical device, when he should've said his product is exempt under the FDA guidance document. Wow.

The problem is, that is such a subtle issue, that your article is likely to leave in the reader’s mind the conclusion that somehow ZKTeco is doing something unlawful. Because of the risk that someone will misinterpret your story to believe that the company is doing something unlawful, I reiterate that we will hold your publication accountable for defamation.

Larry never said he was a lawyer. Larry never said he went to law school. Larry never said that he could opine on what a legal definition means.

Note: Larry Reed is the CEO of ZKTeco USA who represents the company officially and publicly. Moreover, the same 'not a medical device' claim was shared in ZKTeco's FAQ.

ZKTeco's attorney continued:

The fact is medical devices in this category are allowed to be marketed without FDA approval during this pandemic. Period. You are basically arguing that Larry should've said that the products are marketed under the pandemic exemption rather than the medical device exemption. Gosh. You're saying he referred to the wrong exemption for his products. He should've referred to the FDA guidance instead of the medical device exemption, according to you.

If you proceed, you will be proceeding in light of the fact that you know that your story is wrong or likely to mislead, and that makes it intentional. We are not going to put up with you intentionally trying to draw some fine distinction that he used the wrong legal reference in his claim when you know your audience is likely to misinterpret that. You are trying to infer her that somehow he shouldn't be marketing his products, which is legally wrong and you know it. Your intentionality makes this a flagrant violation of the defamation laws.

Medical Devices During a Pandemic

ZKTeco is free to market this product without obtaining FDA 510(k) clearance since April when the FDA announced that it would temporarily "not intend to object" to the distribution of these devices without a 510(k).

However, whether a device is medical or not still matters both during the pandemic and for those looking to use these devices long-term:

  1. The FDA only said it would "not to intend to object" to the distribution of uncleared fever detectors "where such devices do not create an undue risk". The FDA states these devices "will not create such an undue risk where" its "performance and labeling" guidance is "met" and fevers are confirmed with "secondary evaluation methods". If a firm falsely claims their fever device is not FDA regulated and not a medical device, then there is no reason to follow any of this guidance, increasing the chance of creating "undue risk".
  2. In May, the FDA also issued detailed guidance on how to correctly operate these devices. If a company falsely claims their fever device is not a medical device and not FDA regulated, then there is no reason to follow this FDA guidance either. However, as IPVM has repeatedly demonstrated, this guidance exists for a reason: following it is critical to the solution's accuracy and not doing so increases the risk of missed fevers and undue risk to the public.
  3. The FDA policy for the 510(k) requirement is temporary. Once the current public health emergency is declared over by HHS, the FDA will once again require 510(k) clearance for fever detection. Claiming a certain fever detector is not a medical device and thus exempt from FDA regulation misleads users into thinking these products will never require regulatory approval.
  4. ZKTeco is marketing SpeedFace+ products for various functionalities beyond fever detection, including access control and time & attendance that as Reed emphasizes himself, "you'll be using long after the COVID-19 scare is thankfully behind us". However, for buyers to use this device to do temperature / 'fever' detection "long after" the pandemic is over will require ZKTeco to obtain 510(k) clearance.

Conclusion - Market Accurately

While ZKTeco's attorney alleges that we "are trying to infer her [sic] that somehow he shouldn't be marketing his products", we only ask that ZKTeco market its products accurately and fairly. It is important for our "audience", the industry that ZKTeco markets, to properly understand the risks and demands of deploying medical devices now during the pandemic and in the future once the pandemic is over. Encouraging ZKTeco to accurately and fairly market its products as the medical devices they are is better for the companies that buy these products and, more importantly, the public who are depending on these devices during a deadly pandemic.

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Comments (22)

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What is the equivalent of "trunkslammer", but for a manufacturer?

"Made in China"

This type of device is becoming very popular

I am aware of many manufacturers making this and many more that are OEM’ing from said manufacturers

Most of their marketing material use similar language to what ZK is using

ZK has had success in selling this product

They were one of the first to promote and have available inventory

Larry is a nice guy, and I wish him and ZK well

David, thanks for the feedback! When you sell this unit, are you informing your customers about the FDA's performing and labeling' guidance'?

UPDATE: Reed has now edited his post from the past week to remove the term "#feverdetection".

Original:

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Now:

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The responsible thing would be to simply admit that they made a mistake and then fix it. But instead, ZKTeco repeatedly threatens legal action against us while ZKTeco USA's CEO has repeatedly marketed the product as "#feverdetection".

Are there any thermal panels like this that have 510K or working on 510K cert?

What is the appropriate marketing tactic?

#3, good question. In terms of appropriate marketing:

  • Do not falsely market it, i.e., explicitly saying "SpeedFace+ Series models are not medical devices as defined by the U.S. Food & Drug Admin". This misleads buyers into thinking that they do not need to be concerned about medical regulation.
  • Do properly market it, i.e., disclose to buyers that these are medical devices as defined by the US FDA. The seller can certainly explain the current pandemic state and the temporary 'do not intend to object' status so long as no undue risk.
  • Emphasize and explain to buyers / users that FDA "performance and labeling" guidance is "met".

Thoughts?

Update: ZKTeco has now deleted the March 2020 datasheet from its website but we archived a copy of the ZKTeco 'fever' datasheet here.

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is this wrong?

If you have thermometer Z that you use to check temperatures of your food before you eat it: not a medical device

If you have thermometer Z that you use to check skin/body temperatures: medical device

If you have

The point is about manufacturer/seller intent. As cited in the post, from the FDA:

Telethermographic systems are [medical] devices when they are intended for a medical purpose, such as measurement of the self-emanating infrared radiation that reveals the relative temperature variations of the surface of the body

So if a company intended the device to just check temperatures of food, it would not be a medical device. On the contrary, ZKTeco marketed detecting fevers and designed it to explicitly identify 'abnormal' and 'unacceptable' temperatures used to 'deny access' showing their clear intent for a medical purpose.

A similar point was made by a commenter a week ago:

assuming rubber mallets that doctors use to assess reflexes by tapping the knee is classified as a medical devices as defined by the FDA, and you could use a golf club to produce the same assessment. This function of the golf club is of course not the intended use of the manufacturers or downstream marketers.

Did the golf club manufacturer ever market it for use for checking reflexes or design it to be used as such? If they did not, not a medical device. That's the difference between Callaway and ZKTeco.

First thanks to IPVM for your transparent transparency. I doubt this lawyer has experienced a target who posts their complaint and responds to it in public.

Second, we are considering this product DESPITE ZKTeco's overblown and misleading marketing. This is because we are fully informed about the issues involved thanks to IPVM.

Mr. Thompson misunderstands your subsciber base and I am offended by his suggestion that we would be misled by what are CLEAR regulatory distinctions. IPVM is simply informing an educated professional subscriber base so as to allow us to serve our customer base properly.

Clearly Larry (who I like personally and would like to do business with him) agrees with at least some of your criticisms or he would not be editing his posts and product literature.

Lastly, temporarily suspending enforcement of the law is NOT an exemption to the law. Mr. Thompson must know this or he is a poor lawyer indeed (no I am not lawyer but I am not a pro baseball player either and I can recognize a poor player from a great player).

If he has not advised ZKTeco to apply for 510(k) status then he and his firm should be fired. If he has so advised them and they have applied then why not just say that.

I have been a subscriber to Consumer Reports for over 3 decades. I am sure they have received hundreds if not thousands of these letters. I refer Mr. Thompson to the fundamental principle that "Truth is an absolute defense to libel claims, because one of the elements that must be proven in a defamation suit is falsity of the statement. If a statement is true, it cannot be false, and therefore, there is no prima facie case of defamation."

Second, we are considering this product DESPITE ZKTeco's overblown and misleading marketing. This is because we are fully informed about the issues involved thanks to IPVM.

Thanks and fyi, we are testing the 8" ZKTeco version right now as well as the Dahua tablet and the Hikvision 'Minmoe' tablet and expect to release all 3 reports this week.

Looking forward to the testing results. We have been awaiting an evaluation of this product and have several customers very interested. We will be sure to inform of the labeling nuances during our presentation of the solution, regardless of the final product we select.

Another link about defamation and truth

And another

Good example of how ZKTeco's "not a medical device" spreads to integrators in the Indiana video:

Excerpt:

important to note that a lot of the stuff is advertised as fever detecting and it that is not what it's doing so most the problems we have with the industry is that they're promoting this hardware these solutions as medical devices when really all they are is enhanced screening they're really smart we use AI artificial intelligence and machine learning to detect if somebody's wearing a mask if somebody has a temperature that is a surface temperature that's higher than a certain level

So determining if a person's temperature is higher than a certain level (i.e., by default the CDC level for a fever) does not make it a medical device? It's certainly a medical purpose, and that what's what makes it a medical device.

Hey John,

I was surprised to hear about this post from a friend, as I know you have my contact info. I CAN confirm though, that being told that "You made IPVM" is both thrilling and terrifying! Regardless, I will add some context.

This segment was recorded last Thursday and aired Friday evening through Sunday. Your FDA report was posted on Friday. You can bet I did a face palm as soon as I read it. IIB is famously a one-take show and I could certainly have voiced my opinion and purpose more clearly.

What I hoped people would focus on is that we are beta testing this equipment, that we have gone through several tests with various manufacturers and found that the majority of equipment does not do what is advertised and that we are seeking more testing opportunities instead of putting it out there as an end-all be-all, or even a valid solution as presented by the manufacturers. A chunk of that segment was actually dedicated to the other part of our beta test for repurposed thermal cameras which we have a hard time getting behind. Actually, we have a hard time getting behind most thermographic solutions when it comes to this submarket. The ZK in the video was one of two systems we deployed in the Beta test and was sold at our cost in order to gather data (its actually the test unit we bought for our own testing). We are not a "ZK dealer", the test unit was bought through distribution shortly after your presentation with ZK. You may remember me reaching out to get your opinion on the unit. Previous to this test we have installed all of 1 ZK access system... as a favor. The temperature was set at 99.0 degrees.

I am not a huge fan of ZK, but they were first to market with an obviously OEM manufactured device that turns out does a decent job at what WE hoped it would do. (marketing aside) Through my Owners Group, I know of others who have also installed these units who are not "ZK Dealers".

I am surprised that you chose to talk about the ZK talking point instead of the small integrator putting it out there that this stuff is not all its advertised to be, and is doing their own testing with real-world situations. This is in fact the wild-west and it is being capitalized on by all kinds of integration companies large and small without so much as having seen a physical device before selling a "proven solution." That said, it is an interesting application of technology and I believe it deserves (careful) exploration.

From our perspective, these devices should never be used to determine illness, contagious state or fever, we all know the limitations, and quite frankly, nobody is going to consent to a rectal thermometer to go to work, or in this case, a wedding.... nor should they. (A specific scene from Idiocracy comes to mind, tho). The use case here is simply as an indicator of the need for further screening when large amounts of people are coming through a door in a short period of time. If someone scans a surface reading of whatever the property manager sets, they can initiate a more precise and appropriate process. Hardly a flawless process... hence Beta Test.

Best wishes, Keep holding us accountable.

Armando

Armando, Thanks! I changed 'their dealers' to 'integrators'.

the small integrator putting it out there that this stuff is not all its advertised to be, and is doing their own testing with real-world situations

I saw that part but the other part really came off as endorsing the product being shown. Indeed, the way I heard the following portion was that you selected ZKTeco, i.e.:

02:32 we invested in about a dozen different solutions and we came to - one of those is like I said the access control system which looks similar to a tablet and gets mounted on the wall and it does a combination of two different types of temperature reading

As for:

From our perspective, these devices should never be used to determine illness, contagious state or fever

But that's what they are doing, no? Even if you are verifying with an oral thermometer, the ZKTeco or other 'health security device' is first making a medical determination of who is most likely to have elevated tempearture / fever, no? That's clearly the FDA's position.

Btw, the ZKTeco system thinks your beard is a mask in that video:

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To the beard/Mask issue... one of many flaws... it does that more often than not.

This is not an endorsement, its a selection of which products we think show the most promise and we are willing to invest in further testing with.

So points to Armando for engaging in the discussion and clarifying his intent. Please continue this dialog as many of us integrators are being pressed for options by our customers and we all benefit from this discussion.

Also, bonus points for referencing Idiocracy. Those who haven't seen it, see it now. For those who have seen it, see it again. Social commentary inside a stoner comedy. Brilliantly Stupid.

I see that the FDA is referencing ‘thermographic’ sensor equipped devices...

Are they also including the lower cost, less accurate (in most conditions) ‘thermopile’ sensor equipped devices in the same context?

For further clarification, the entire video and editorial with context can be found here:

Indy Company Testing Health Security Technology - Inside INdiana Business

other relevant excerpts:

Hoosier Security says demand for such systems is high, but the market is saturated with equipment that may not deliver on its promises

we immediately noticed a problem with how they were doing it in that that equipment is not designed for that use case;

Perez says they also started to see issues arise with HIPAA and the National Defense Authorization Act r

We reached out to partners and companies within the Midwest, generally speaking, and had them agree to help us test this and in exchange, they would give us information for a case study."

However, Perez says the technology has been problematic

"That's where this beta program has really been really eye-opening because we see a lot of companies buying that equipment at full retail and we just know for a fact that it's not going to work as intended."

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