ZKTeco SpeedFace+ Are Medical Devices, Per FDA Definition, Contrary Claims Are FalseBy: John Honovich and Charles Rollet, Published on Jun 12, 2020
ZKTeco SpeedFace+ series products are medical devices as defined by the US FDA. Contrary claims made by ZKTeco are false.
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
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.
ZKTeco's CEO markets this product as "#feverdetection", showing he clearly knows the intent of this product is medical:
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:
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.
Moreover, ZKTeco's CEO is simultaneously promoting their body temp detection to reopen businesses shut down by coronavirus:
Reed emphasizing here he knows that 'body temperature detection' is being used during the "COVID-19 scare":
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]
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:
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:
The company from the beginning has intended this to be used to detect fevers as their March 2020 datasheet repeatedly declares:
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:
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
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:
- 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".
- 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.
- 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.
- 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.