ECGC-70-002, Rev. 8, February 05, 2019
7
Mode, after your prescription has been approved you will see your ECG displayed in real
time as it is recording. If you are in Over-the Counter mode you will see the 30-second
recording "Progress Bar" fill up while the system records your ECG after which the result
will be displayed as Green (Normal), Red (Irregular) or Yellow (Unable to read).
The ECG Check is not intended for diagnostic use and does not provide diagnostic
quality ECG data.
Contraindications
There are no potential adverse effects of the ECG Check on health.
Indications for Use
The ECG Check Universal family of devices is intended for self-testing at home. These 1-
lead cardiac monitors allow remote patients to display and transmit their EGG data to
medical professionals via a communication device to a remote server.
Specifically, the EGG Check Universal models are indicated for patients who are
concerned about their heart rhythm and have experienced the following symptoms that
are suggestive of abnormal heart rhythms:
Skipped Beats
Pounding Heart (Palpitations)
Heart Racing or Irregular Pulse
Lightheadedness or Faintness
History of Arrhythmias
Description
General Description
The ECG Check is a medical device that allows recording and sending of an ECG
recording (using Bluetooth technology). The recording is sent to a device (ECG Check
Application compatible cellular device). This allows you and your physician to monitor
your health information (ECG) from anywhere any time you wish.
