FOR VA PROVIDERS & PROSTHETICS
Helping Veterans Access Encora X1 Through the VA
FDA-CLEARED | PRESCRIPTION REQUIRED
Every step of bringing Encora X1 to veterans with essential tremor is designed to be straightforward, from clinical evaluation and prescribing to ordering and ongoing patient support.
Why VA Teams Choose Encora
Built For VA Care Teams
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FDA-Cleared
510(k)-cleared for adults with essential tremor.
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Simple VA Ordering
Designed to fit within existing VA Prosthetics workflows.
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Direct-To-Patient Fulfillment
Encora X1 ships directly to the Veteran’s home.
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Continued Patient Support
Dedicated Patient Advocates help Veterans long after delivery.
CLINICAL INFORMATION
For VA Neurologists & Clinicians
Clinical Overview
Expanding Treatment Options For Essential Tremor
Encora X1 is the first FDA-cleared, non-electrical wearable therapy for essential tremor, designed for patients whose tremor isn’t adequately managed with medication and for whom surgery isn’t yet appropriate.
It fills an important treatment gap by fitting alongside a patient’s current treatment plan. Because Encora X1 uses mechanical, rather than electrical, stimulation, it has no electrical contraindications and can be considered for patients with implanted electrical devices.*
FDA Clearance: 510(k) K251517Indication For Use: Encora X1 is indicated to aid in the relief of hand tremors in the treated limb during stimulation in adults with essential tremor. Rx Only. Talk to your doctor about whether Encora X1 is right for you. Individual results may vary.
Disclaimer: Encora X1 is not a cure for essential tremor. Individual results may vary. In clinical trials, all device-related adverse events were non-serious, temporary, and self-resolving. Reported side effects include numbness (3%), buzzing/tingling sensation (3%), discomfort/pain (1.5%), skin irritation/rash (<1%), muscle weakness (<1%), and possible temporary worsening of tremor (<1%).
*Encora X1 has no electrical contraindications. Compatibility with implanted electrical devices is based on bench testing per IEC 60601-1-2. Bench test results may not necessarily be indicative of clinical performance.
Patient Selection
When To Consider Encora X1
Consider Encora X1 for adults with essential tremor who:
- Cannot tolerate medication or prefer a non-drug option
- Need an additional option when medication alone is not providing enough relief
- Have an implanted electrical device and need an option with no electrical contraindications
- Are not ready for, or are not appropriate candidates for, surgical options
Evidence
Studied In The ULTRE Clinical Trial
Encora X1 was evaluated in the ULTRE pivotal study and a 90-day home use study in adults with essential tremor. Full study design, endpoints, and publications are on The Science.
Observed benefit within 30 minutes of use
Defined as a one-point BF-ADL improvement after 30 minutes of stimulation, compared to 48% of the sham group.
ULTRE pivotal study- 78%
Observed benefit after 90 days of use (pooled responder rate across both cohorts)
90-Day Home Use Study - 96%
Rated therapy comfortable all of the time
ULTRE pivotal study
Download PDFEncora X1 Clinical Evidence Whitepaper
Encora X1 is not a cure for essential tremor. In clinical trials, all device-related adverse events were non-serious, temporary, and self-resolving. Reported side effects include numbness (3%), buzzing/tingling sensation (3%), discomfort/pain (1.5%), skin irritation/rash (<1%), muscle weakness (<1%), and possible temporary worsening of tremor (<1%).
Prescribing
Three Simple Steps To Get Started
Evaluate
Confirm the patient is an appropriate candidate for Encora X1.
Submit
Submit through your facility’s standard VA consult, prescription, or ordering process.
Include the Encora X1 patient and product information from the Provider Quick-Start so the correct system can be fulfilled. If prescribing for both hands, two devices are needed, one dedicated to each hand.
Get Support
Encora Product Support and Lovell Customer Service coordinate the order with VA Prosthetics. Once the order is complete, an Encora Patient Advocate helps Veterans get started and provides ongoing support throughout therapy.
Recommended Consult Language
Requesting Encora X1 (FDA 510(k) K251517), a wrist-worn mechanical neurostimulation device indicated to aid in the relief of hand tremors during stimulation in adults with essential tremor. This patient is an appropriate candidate. No substitutions.
Reordering
A Full Year Of Therapy, Then A New Evaluation
Each prescription is valid for 12 months of therapy. Wristbands are designed for 90 days of use and must be replaced every 90 days. Four wristbands provide a full year of therapy. A new clinical evaluation and prescription are required for Veterans who continue therapy beyond the initial 12-month prescription.
Every Veteran is paired with an Encora Patient Advocate for onboarding and ongoing support, so your clinical and procurement teams can stay focused on caring for Veterans—not troubleshooting devices.
Still Have Questions?
Request An Educational Session Or Prescriber Kit
Want a walkthrough for your team or materials for your clinic? Request an educational session or a prescriber kit and the Encora team will follow up.
ORDERING INFORMATION
For VA Prosthetics & Sensory Aids (Procurement)
Product & Fulfillment Process
Ordering Encora X1 for Your Veteran
Encora provides product, fulfillment, and patient-support information. Lovell Government Services provides federal procurement and ordering support.
Follow Your Facility’s Process
VA facilities may use different vendor, consult, and purchase procedures, and Lovell Customer Service can confirm any required procurement steps or forms.
Review the documentation
Confirm the prescribing provider’s documentation includes the patient and Encora X1 information needed for fulfillment.
Submit the purchase order
Send the PO to Lovell Customer Service using the purchasing information below.
Confirmation
Lovell Customer Service confirms receipt and contacts the designated VA point of contact if additional information is needed.
Shipment
Encora X1 ships to the Veteran’s home or the VA facility, as specified on the purchase order.
Onboarding education
An Encora Patient Advocate contacts the Veteran within 24 hours of shipment to provide onboarding education and ongoing support.
Download PDFVA Prosthetics and Procurement Quick Start Guide
Questions? Contact Lovell Customer Support at (850) 684-1867
Submitting The Order
Four Ways To Send A Purchase Order
- Call(850) 684-1867Lovell Customer Service
- OnlineGSA Advantage or ECATFederal marketplaces
- Fax850-254-9853Purchase order
- Emailcustomerservice@lovellgov.comPurchase order
Government Purchase Card
Lovell accepts the Government Purchase Card for open-market purchase.
Submit the purchase order using the purchasing information below. Lovell Customer Service will coordinate payment with the designated VA point of contact and provide a receipt after the transaction is completed.
Purchasing Information
What You May Need To Set Us Up And Cut A PO
- Manufacturer
- Encora Therapeutics
- Product
- Encora X1
- FDA clearance
- 510(k) K251517
- Product code
- QBC
- CAGE code
- 71G35
- UEI
- MNH3STM1FTS6
- P-card accepted
- Yes
- Estimated lead time
- 3–5 business days plus shipping
- Unit pricing
- Refer to price sheet
Indication: Encora X1 is indicated to aid in the relief of hand tremors in the treated limb during stimulation in adults with essential tremor.
Common Questions
Questions From VA Teams
Does an Encora X1 order require prior authorization?
VA facilities may use different vendor, consult, and purchase procedures. Follow your facility’s standard process. Lovell Customer Service can confirm any required procurement steps or forms.
How do I get pricing?
Request pricing through your Encora Therapeutics Sales Rep, through Lovell, or view current pricing on GSA Advantage or ECAT.
How do we determine band size?
Band size is based on wrist circumference in centimeters: S is 14.5–16.5 cm, M is 16.5–18.0 cm, L is 18.0–20.0 cm. At a shared boundary, select the smaller band size. See the Encora X1 Wrist Measurement Guide in the resources above.
Who do we call — Encora or Lovell?
Encora Therapeutics for product questions, education, patient selection, prescribing, shipping, and patient support. Lovell Government Services for product orders, purchase orders, payment, and vendor setup.
What ships with a 12-month prescription?
One Encora X1 Device for Essential Tremor with its Charging Station, a charging cord, and four Encora X1 Wristbands. Wristbands are designed for 90 days of use, so four provide a full year of therapy.
Who supports Veterans after delivery?
An Encora Patient Advocate contacts the Veteran after device shipment to provide onboarding education and ongoing support. Patient Advocates handle advocacy and onboarding, not clinical care, which stays with the VA care team.
Where do I find contraindications and safety information?
Full safety information, warnings, and contraindications are on the Important Safety Information page, linked in the resources above, and in the Instructions for Use.
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