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Prescription Requirements for WellPD (US-only)

First purchase WellPD, then upload your prescription. We can’t accept an order based on a prescription alone. This is due to FDA regulations and is unrelated to insurance reimbursement.

WellPD is a prescription-only, FDA-cleared medical device, used as an adjunct to Parkinson’s monitoring for adults, at home or in healthcare facilities.

Orders placed through our US store require a valid prescription from a US doctor or healthcare practitioner before shipment. This requirement applies to:

  • US residents purchasing and using WellPD locally
  • International customers purchasing from the US, intending to use WellPD abroad

Why is a prescription necessary?

WellPD is a prescription-only device. Your doctor knows your medical history, so they need to confirm that WellPD is suitable for you.

What must the prescription include?

To make this easier, we have created a prescription template for your doctor to fill out.

Before you submit it, make sure it meets these FDA 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.
  • “WellPD” listed as the prescribed item.
  • Patient’s full name.
  • Patient’s date of birth.
  • Patient’s diagnosis code (e.g., ICD-10 code for Parkinson’s disease).
  • Doctor’s signature (handwritten, or digital with a visible date and time).
  • Date of issue.

Your prescription must include all of the above to be valid.

Tips

Please ensure your doctor completes all required details on your prescription before submitting:

  • Make sure all written details on the prescription are clear and easy to read.
  • Ask your doctor specifically for their 10-digit NPI number. This identifier is different from a state license number or a DEA number.
  • You can verify that your doctor’s NPI is active and valid on the NPI Registry.

For more on uploading your prescription, see: How to upload a prescription for WellPD.

Due to FDA regulations, WellPD is for single-use only. It is not intended to be shared with, sold to, or transferred to another person. For more information, see the FDA Clearance Summary.

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