Why do I need medical clearance to access the ECG feature?
ScanWatch 2 is an over-the-counter device, however, its ECG feature has been tested and cleared under Rx by the FDA. As such, ECG permissions are reviewed and validated for free by a health professional who will deliver a prescription for continued use.
Again, activating the ECG approval process is completely free, and you will not be charged whether you are approved or not for continued ECG use. In the meantime, we’ve begun the process of working to make the ECG functionality fully available to users without a prescription or additional costs, and look forward to keeping you updated.
Note: The price of ScanWatch 2 will remain the same even after ECGs are available without requiring an Rx.
What is the ECG validation process?
The first electrocardiogram recorded by your ScanWatch 2 is sent to a medical organization, Heartbeat Health, which is able to review the data and issue a prescription to authorize the permanent use of the ECG feature.
Please keep in mind that this process is entirely free of charge as you already paid for the watch. Here is how it works:
- We ask for information about you: name, date of birth, email address, and phone number depending on your state’s regulations.
- We ask you to consent to sharing information with Heartbeat Health.
- We ask you to take an ECG measurement, but you will not be able to see the results immediately. You will be able to find them in the app once the feature has been enabled.
- We send the ECG information to Heartbeat Health that will provide feedback within 48 operating hours.
Depending on your state’s regulations, you might be contacted by our partner Heartbeat Health to get on a call with a physician — at no additional cost to you, except possible message and data rates — only if you wish to ask questions or discuss the ECG feature. Again, nothing is mandatory, and all actions are free of charge.
Withings App says I’m too young to use the feature. Why?
The ECG feature is only available to people over 22 years of age as it is intended for adult users. The FDA considers adolescents as everyone from 12 through 21 and disapproves of the use of non-pediatric medical devices by adolescents for safety and efficiency reasons. Withings willingly complies with this policy, and the same rule actually applies to all smartwatches and/or medical devices cleared by the FDA. See the ScanWatch 2 information guide. [FILE NEEDED]
Note: Make sure to get in touch with the support team to restart the ECG activation process once you come of age.
Why do I have to provide my phone number?
Depending on the state you live in, you may be asked to provide your mobile phone number in order for our partner Heartbeat Health to contact you if needed. As an example, in certain states, your phone number is requested to reach out about the ECG feature activation. This is required for Withings to ensure compliance with Rx regulations.
Note: only US mobile numbers are allowed.
I have an error message in my app. What does it mean?
You might get an error message for one of three reasons:
- You are 21 or younger: the ECG feature is not accessible for you just yet. Make sure to get in touch with the support team by clicking the Contact Us button at the bottom of the page to restart the ECG activation process once you come of age.
- You selected Other when asked which state you live in:
if you are a US resident, you need to disclose the name of your state.
If you do not live in the US but are receiving this message, please contact our support team by clicking the Contact Us button at the bottom of the page.
- You selected I cannot receive SMS if asked for your phone number:
if you have a phone number but don’t feel like providing this personal information, please understand that you won’t be able to use the ECG feature. Rest assured that Withings complies with all data protection regulations as explained in our privacy section.
If you do not have a mobile phone and really can’t provide any number, please contact our support team by clicking the Contact Us button at the bottom of the page.