RESPeRATE For Lowering Blood Pressure and Stress Reduction

Indication for Use (FDA 510K# k020399)

RESPeRATE is intended for use as a relaxation treatment for the reduction of stress by leading the user through interactively guided and monitored breathing exercises. The device is indicated for use only as an adjunctive treatment for high blood pressure together with other pharmacological and/or non-pharmacological interventions.

Over-the-counter Use

Contraindications: None known.

Precautions

Please note: RESPeRATE should only be used as part of your overall health program for achieving goal blood pressure, as recommended by your doctor. RESPeRATE can be safely used in conjunction with medication and lifestyle modifications such as diet and exercise.

Do not use this device without consulting your physician if you suffer or have suffered in the past from: active ischemic heart disease/unstable angina, severe congestive heart failure, chronic atrial fibrillation, stroke resulting in permanent impairment, chronic renal failure, severe asthma, chronic obstructive pulmonary disease (COPD), like chronic bronchitis and emphysema, or major organ failure.

InterCure strongly recommends that you do not modify your hypertension treatments without the advice and consent of your physician.

Do not use your RESPeRATE when you need to be alert or to concentrate, or when using heavy equipment. Do not use RESPeRATE while driving.

If you experience any side effects or if you feel any change in your general health or mood, immediately discontinue use of your RESPeRATE, and contact your physician.

Breathe naturally throughout the exercise. Excessive deep breathing may cause dizziness and/or palpitation.

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