USFDA’s definition of the TENS class does not distinguish between the higher and the lower levels of current, voltage, and frequencies (such as muscle-contracting devices). Therefore, the user should be aware that the information listed below is not representative of the products covered but they might apply.
Intended Use:
Avazzia BESTTM devices are USFDA-cleared as Transcutaneous Electrical Stimulation (TENS) for the medical intended use.
Read all instructions, warnings, and precautions as well as the Owner’s Manual before using the device. It should be used only for the purpose for which it is intended. Devices are not intended for diagnosis or treatment of disease conditions.
The device is not a replacement for professional health care.
DANGER
The device can generate output pulses of up to 650 Volts. To avoid skin irritations such as burns, do not use device for prolonged periods of time in a single location, while sleeping or other unattended use.
Misuse could result in fire hazard.