Intended Use of Heart Rate



• NORA Smart Sock reads heart rate for sleep tracking, sleep training and other general wellness purposes. Heart rate slows down when baby starts to fall into sleep. Reading the heart rate helps the parents to know how shallow or deep the baby is sleeping, which is very helpful for sleep tracking and training. For example, parents can put the baby down into crib if the heart rate starts to slow down, which is one example of practicing sleep training. The heart rate reading is used in sleep tracking algorithms as well. An example of general wellness is NORA can detect elevated heart rate (in healthy range) in feeding.

• NORA Smart Sock ceases the function of “out-of-zone notification on heart rate”. The notification on heart rate function will be permanently removed to prevent misleading marketing, wrong expectation, wrong impression or user abusing. All marketing pages including but not limited to Amazon.com and NORA.CARE has been corrected. All marketing starts to deliver corrected information consistently since NOV 20th 2021. The hardware and software functions are being phased out with respect to Apple's App review process.

• NORA Smart Sock does NOT intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

BACKGROUND

On OCT 5th 2021, the United States Food and Drug Administration (FDA) sent an open warning letter to another wearable baby monitor company. The warned company is NOT NORA. (With respect to our competitor and in the spirit of fair market competition, we don’t mention their company name here.) In the letter, the FDA pointed out that “Products that measure blood oxygen saturation and pulse rate are devices when they are intended to identify (diagnose) ... and provide an alarm to notify users that measurements are outside preset values.”

Reading the FDA’s letter to our competitor, NORA CARE LLC gained more knowledge on how devices are categorized and what is the criteria of it. In the spirit of being proactive and responsible, NORA CARE LLC decided to conduct a series of checking on ourselves as well since OCT 2021 and make all necessary corrections since NOV 2021. NORA CARE LLC, as a startup of 2-years-old, appreciates FDA's open letter as a precious educational material.

CORRECTIONS IN NOV. 2021

Consistently and further explicated that the intended use of heart rate reading cross all product pages and labels. The only intended purpose of NORA Smart Sock heart rate reading is sleep tracking and training. Reading the heart rate helps the parents to know how shallow or deep the baby is sleeping, which is helpful for sleep tracking and training. For example, parents can put the baby down into crib if its heart rate starts to slow down (in healthy range), which is one example of practicing sleep training. The heart rate reading is used in sleep tracking algorithms.

Made sure that every single time that the words “heart rate” is used in marketing, the above intended use message is clearly delivered to users. Due to the long establishment of our competitor’s incorrect marketing, users tend to have a default impression that reading heart rate is for out-of-zone notification. To make sure that users got the correct information associated with NORA’s product, NORA CARE LLC decided to mention the intended use of heart reading is for sleep tracking and training every single time that the words “heart rate” is mentioned.

Made sure that every single time that the words “heart rate” is used in marketing, it’s clear to users that NORA Smart Sock does NOT provide any notification or alert function on heart rate readings. This is in case that users still got an incorrect expectation caused by long-established impression of competition product(s) in the market. Based on our experience, our competitor’s marketing and influence over the past years has made many users to make an illusory connection between all “Smart Sock” in the market to “Out-of-zone Oxygen and Heart Rate Alert”. One example is some of NORA’s users returned our products because they *think* it has oxygen tracking, although NORA never had such function and we never used the words “Oxygen” or “SpO2” in marketing.

Stopped all marketing of “Out-of-zone Notification on Heart Rate”. Examined that all pages, labels and instructional printings. The sleep position notification, ambient temperature notification and movement notification in are kept.

Disabling the function of “Out-of-zone Notification on Heart Rate” in hardware and software. The notification function will be permanently phased out to prevent misleading marketing or user abusing. It takes a little bit time for us to upgrade all software, firmware, hardware and user manual to gradually phase it out, especially because iOS App requires us to prepare certifications and go through Apple’s review process. The current progress is only the software (iOS and Android) has not been updated yet. Expect to update the Android App first by th end of 2021.

Ceased the planned release of “Oxygen Level (SpO2) Reading and its Notificaiton”.

SINCE NOV. 2021

NORA Smart Sock continues to read heart rate for sleep tracking and training purposes.
No more provide notification or alert function on heart rate reading.

NORA Smart Sock continues to provide the following notifications:
Sleep Position Notification (On-back / On-side / On-stomach)
Ambient Temperature Notification (High / Low)
Movement Notification (Under Development)





NORA CARE LLC, California

NOV 20th 2021