Intended Use
Avazzia BEST devices are US FDA Cleared for Transcutaneous Electrical Nerve Stimulation (TENS) for:
- Prescription use for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment in the management of post-surgical and post-traumatic pain.
- Over-the-counter use for the temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Refer to the owner’s manual included with your device for complete instructions, warnings, and precautions. Read all safety instructions before use. Use only as directed.
This device is not a replacement for professional healthcare.
If you are unsure about safe use or do not know the cause of your pain, talk to your physician or other healthcare provider.
Contraindications
Do not use if you have a demand-type cardiac pacemaker, implanted defibrillator, or other implanted electronic device. Such use could cause electric shock, burns, electrical interference, or death.
Do not use while pregnant or nursing.
Do not use this device if you have undiagnosed pain syndromes until the underlying cause has been determined.
Warnings
For external use only on normal, intact, clean, healthy skin. Keep out of reach of children. Do not use over the carotid sinus or carotid sinus nerves, or on the front of the neck or over the thyroid. Do not apply stimulation through your chest (transthoracically) or through the head (transcerebrally).
Precautions
Consult with your healthcare provider before using the device if you have heart disease or epilepsy. Follow your doctor’s instructions when using after an injury or surgical procedure.
Adverse Effects
Skin irritation or burns beneath the electrodes have been reported with TENS use. Follow instructions carefully to prevent injury. If you experience any adverse reactions, discontinue use and consult with your doctor.
