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If you are a Study Participant, contact your Administrator directly as information in the Support Center is intended for qualified researchers and healthcare professionals. Misapplying the information below may affect your data collection.

Prescription Requirements for EpiMonitor

If you are an Embrace2 user looking to switch to EpiMonitor, you will need a new prescription with the below requirements.

Customers who purchase and use EpiMonitor within the US territories will be required to upload a valid prescription issued by a US doctor or healthcare practitioner before EpiMonitor can be shipped to them.

 

Please note that if you are buying EpiMonitor in the US for someone who resides outside the US, you will still be required to submit the prescription for the user.

 

Why is a prescription necessary?

EpiMonitor is a prescription only FDA-cleared medical device so it is necessary that your doctor, who understands your medical history and seizure types, agrees that it is suitable for you.

 

 

What must be included in the prescription?

To make the process smoother, we have created a prescription template for you to share with your doctor. All they have to do is fill out this form.

Before submitting the prescription, please make sure that it meets the following FDA prescription requirements:

  • National Provider Identifier Number (NPI) of the healthcare practitioner who issued the prescription.
  • Full name of the healthcare practitioner.
  • Address of the healthcare practitioner.
  • "EpiMonitor" is listed as the prescribed item.
  • Patient's full name.
  • Patient's date of birth.
  • Doctor's signature (hand-written or digital with visible date and time is necessary for digital signatures).
  • Date of issue.

All of the above must be indicated on the prescription for it to be considered valid.

 

Tips

Please make sure that your doctor fills in the prescription with all of the requirements above. The NPI number is not substitutable for the license number or DEA number, so please make sure to ask your doctor specifically for that. The NPI number is a 10-digit unique identifier that all registered healthcare providers must have.

In addition, please make sure the prescription is legible.

 

For more information on how to upload your prescription, please refer to: How to upload a prescription

 

 

EpiMonitor is a prescription only FDA-cleared medical device that is indicated for use as an adjunct to seizure monitoring of adults and children ages 6 and up in home or healthcare facilities during periods of rest.

Due to the FDA regulations, please note that EpiMonitor should be used for one patient only. It is not intended to be shared with, sold to, or transferred to another person. For more information, please refer to the FDA Clearance Summary.

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