M.D.D FDA (510(k)) K032178

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The Rhythm Touch™ is intended for use by Adults only.

The FDA mandates that manuals prominently display contraindication, warnings, precautions and adverse reactions, including: no use for wearer of pacemaker; no use on vital parts, such as carotid sinus nerves, across the chest, or across the brain; caution in the use during pregnancy, menstruation, and other particular conditions that may be affected by muscle contractions; potential adverse effects include skin irritations and burns.
 

Rhythm Touch™ pads should never be placed:

  • On or near the eyes
  • In the mouth
  • Trans-cerebrally (On both temples)
  • On/near the heart, or across the chest because the introduction of an electrical current into the chest may cause rhythm disturbances to the heart.
  • On the front of the neck (Due to the risk of acute hypotension through a vasovagal reflex)
  • Directly on the groin such as, ie: on the penis or testicles
  • On areas of numb skin/decreased sensation
  • On broken skin areas or wounds
  • On or near the trigeminal nerve if you have a history of herpes zoster induced trigeminal neuralgia (Postherpetic neuralgia)

CONTRAINDICATIONS

  • The Rhythm Touch™ MUST NOT be used on patients or persons with cardiac pacemakers (especially of the demand type), defibrillators, or other electronic or metallic implants.
  • The Rhythm Touch™ should not be used during pregnancy, because it may induce premature labor. (Do not use over area of the uterus as the effects of electrical stimulation over the developing fetus are not known).
  • DO NOT USE if you have from epilepsy, cancerous lesions, abdominal or inguinal hernias, critical ischemia of the lower limbs or blood flow deficiencies/venous thrombosis.
  • The Rhythm Touch™ should not be applied over the carotid sinuses due to the risk of acute hypotension through a vasovagal reflex.
  • DO NOT USE post, acute trauma or recent surgical procedures.
  • The Rhythm Touch™ should not be placed over the anterior neck, because laryngospasm due to laryngeal muscle contraction may occur.
  • The Rhythm Touch™ should be used cautiously in patients with a spinal cord stimulator or an intrathecal pump.

PRECAUTION

Before using the Rhythm Touch™ please consult your physician if you have any of the following conditions:

  • Malignant tumor
  • Heart/acute/infectious diseases
  • High fever
  • Abnormal blood pressure
  • Skin sensory disorders or skin problems
  • Hernias - Abdominal or Lingual
If you suffer from a serious medical condition, consult your physician before using the Rhythm Touch™ or any other electrical therapy device.

The Rhythm Touch™ should only be used with leads, pads and accessories made by Rhythm Touch™.

Keep the Rhythm Touch™ out of the reach of children.

 


***The Rhythm Touch™ is not intended for use in the diagnosis, treatment or prevention of any disease
and/or any other medical condition.

 
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