COVID-19 Alert to all Healy Members: Currently there are no FDA approved therapies to treat or prevent COVID-19 (Coronavirus). Neither is the Healy intended to diagnose or treat any disease, including COVID-19. Healy is a microcurrent medical device cleared by the U.S. Food and Drug Administration only for local relief of acute, chronic, and arthritis pain and muscle soreness due to overexertion. Healy also has non-medical applications that use individualized frequencies to help balance your mind and body and relieve stress in support of wellness but not for the treatment of disease. Healy World supports and encourages the practice of COVID-19 preventive measures published by the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC). If you, your family, or customers experience any of the COVID-19 symptoms as described by WHO and the CDC, we urge you to seek medical diagnosis and treatment.

Indications and Risks

Indications

The intended use of Healy includes the following fields of application:

  • in pain management (chronic pain, fibromyalgia, skeletal system pain, migraine)
  • in case of mental illnesses such as depression, anxiety and associated sleep disturbances

Contraindications

Microcurrent treatment must not be performed when metallic foreign bodies are in the area of treatment, pacemakers or implanted defibrillators are present, bleeding, risk of bleeding or embolism are present. Treatments must not be performed on areas of the skin which have been treated radiotherapeutically or have a sensory disorder or if the user has a fever.

  • Not for use by pregnant women
  • Not for use by those with epilepsy or heart disease
  • Do not place the electrodes on the eyes, neck or over your heart (area below both collarbones down to the end of the breastbone and midline from the left axilla to the level of the end of the sternum) Consult a medical professional before using if you have any of these contraindications.

Possible Side Effects

Possible side effects are usually very mild and subside within a few days after interrupting the application. The following side effects have been observed:

Occasional (1 in 1,000 applications):

  • Strong tingling under the electrodes
  • Allergic reaction to the electrodes
  • Skin irritation
  • Dizziness
  • Headaches

Rare (1 in 10,000 applications):

  • Punctiform wounds after stimulation

Very rare (1 in 100,000 applications):

  • Hematoma formation at the electrodes
  • Pain at the electrodes

Not known (frequency cannot be estimated based on existing data):

  • Loss of vision
  • Stiffness of the locomotor system
  • Tachycardia

Prolonged CES treatment at currents higher than necessary may cause dizziness or nausea that can last for hours to days. Treatment immediately prior to going to sleep may cause difficulty sleeping. Paradoxical reactions such as increased anxiety, and sleep disturbances may occur, but are rare.

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