Disclaimers

Indication 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.

Clinical Study Disclaimer

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%).

Clinical data from the ULTRE feasibility study (N=43 effectiveness) and the 90-Day Home Use study (N=59 effectiveness) on file. Results are descriptive. Individual results may vary.

Implant Compatibility Disclaimer

Encora X1 has no electrical contraindications. Compatibility with implanted electronic devices is supported by bench testing conducted in accordance with IEC 60601-1-2. Five participants with implanted electronic devices were included in the 90-Day Home Use Study. This limited clinical experience may not be representative of all patients or implanted devices. Talk to your doctor before using Encora X1.

WEB-017 REV0