Indications for Use

The Felix NeuroAI™ Wristband is indicated to aid in tremor-related functional limitations in the upper limbs in adults with essential tremor.

Contraindications

This product should not be used in the following cases:

By people with an implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator.
By people with suspected epilepsy or confirmed epilepsy.
By people who are pregnant.
On swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions.

Warnings

Do not use this device in the environment of high-frequencysurgical equipment, which may cause burns, and/or equipment failure. Do not use this device within 3.3 feet (1 m) of short wave or microwave therapy equipment, which may cause the output of the Stimulator to become unstable. Wearing this device is not recommended during X-ray examination, as it may interfere with the diagnosis. Do not use this device near high-power equipment, such as high-voltage cables, ultrasonic equipment, or defibrillators, and do not use this device under a strong electromagnetic field (such as medical radio frequency equipment that radiates interference signals or electrical fast transient/burst signals).
This device is not safe to use with magnetic resonance (MR) and should not be worn in a magnetic resonance imaging (MRI) scanner.
Keep this device 6 inches (15 cm) away from magnetically susceptible medical devices, such as cochlear implants, neurostimulators, stents, and shunts.
This device can only be worn on the wrist. Do not use in non-wrist areas, such as the head, eyes, mouth, heart, neck (carotid sinus), chest, and upper back. Doing so may lead to health problems.
Do not use this device during the following activities:
- Sleeping;
- Driving;
- Bathing or swimming;
- Operating machinery;
- Any activity where an involuntary muscle contraction could cause an injury.
Do not use this device near flammable liquids, smoke or chemicals.
Stop stimulation while refueling a vehicle with gasoline to prevent the risk of explosion or injury.
Do not stimulate open wounds, cancerous lesions, rashes, areas with excessive swelling, redness, infection, or inflammation.
Stop stimulation if you want to remove or charge the device.
If the stimulation intensity is too high, it may cause discomfort or skin irritation.
The long-term effects of chronic electrical stimulation are unknown. When the stimulation intensity in the calibration page of the Felix NeuroAI App is set to 8 or above, the user should be especially mindful of potential risks associated with electrical stimulation at this intensity.
Do not immerse the device in water and do not use it in high humidity places, such as the bathroom.

Cautions

Users must read the IFU carefully before using this device.
Only use the Electrode and Connector bands made by the manufacturer.
Safety of the Felix device during pregnancy has not been established.
The Stimulator and the Connector Band need to be cleaned and disinfected regularly. Follow the instructions in Section 5.3.
Avoid dust, direct sunlight, and pests when storing, and it is recommended to store it in the original package when not in use.
When this device is not in use, keep it out of the reach of children and pets.
Avoid condensation forming on the device. When moving the device from a cold to a warmer environment, place it in a sealed plastic bag and allow it to gradually reach thermal equilibrium.
Before use, the skin should be cared for according to Section “2.5 Skin Care Guidelines” in this manual.
Use with caution in patients with skin sensory disorders or skin abnormalities.
Use with caution in patients with atrial fibrillation, bleeding, or clotting disorders.
Patients with an implanted device near the proximity of the stimulation site should consult a doctor about whether they can use this device.
The following patients should use Felix under the supervision and assistance of caregivers who are familiar with the use of this device:
- Elderly patients who are unable to operate the device independently;
- Patients who are receiving medication that affects memory, comprehension, or ability to perform operations;
- Patients with cognitive impairment.
To avoid product damage and malfunctions, please note the following activities:
- Do not place the device on, in, or near a heat source. Overheating may damage the device or battery, and may cause an explosion of the device or battery;
- Do not drop the device on a hard surface as this may damage the device and/or the battery;
- The Stimulator case may crack if the device falls or hits significantly. Do not use the device if the case breaks, as it may cause injury;
- Do not contact the electrodes with other conductive parts (including grounding), and do not expose the device to electric shock or expose device to any static electricity;
- Do not disassemble or modify the device. This is unsafe and not permitted. The device’s battery is not user-serviceable. Attempting to replace it may cause damage or create safety risks.
When charging, do not place the charger on a metal table, and remove metal objects from nearby the device to avoid heating of metal foreign bodies.
Do not use the device during charging.
Do not dispose of this device in the trash. Disposing of the device and its accessories and packaging (including internal battery, plastic bags, foam, carton) shall comply with local laws and regulations.

Adverse Reactions

The following are possible minor/moderate risks or adverse reactions that may occur with the use of the device:

Discomfort with stimulation, such as stinging, electrical tingling, skin pain, soreness, weakness, nausea;
Skin irritation, such as redness, itchy skin, flaky skin, bumpy rash, electrical irritation, burns;
Skin discoloration (darkening or lightening of skin tone);
Unintended muscle contractions;
Worsening of tremor;
Worsening of arthritis of the hand, or joint pain.

In the unlikely event that any of the following more significant issues occur, stop using the device immediately and contact the supplier where you received the device:

Signs of significant and persistent discomfort with stimulation, skin irritation, ulcers, electrical irritation, burns, or signs of injury;
Significant or sustained increase in muscle tightness or stiffness;
During the stimulation process, there is a sense of pressure in the chest;
Swelling of the arms, wrist, or hand.

Last Updated: January 22, 2026 (Version 1.3.2)