Analgesic TENS system

Intended purpose

The Mendie Wireless TENS + Heat Therapy Device is a non-invasive, rechargeable, wearable medical device intended to provide temporary relief of pain and muscle tension through the combined application of transcutaneous electrical nerve stimulation (TENS) and therapeutic heat. The device delivers low-voltage electrical pulses through adhesive electrode pads placed on the skin’s surface. These gentle electrical impulses stimulate sensory nerves, activating natural pain-modulating mechanisms within the nervous system, commonly described as the “pain gate control” theory. This process helps to reduce the perception of pain, increase local circulation, and promote muscle relaxation without the use of medication or invasive procedures. In addition to TENS functionality, the Mendie device includes a controlled heat therapy mode. The heat element provides consistent, mild warmth to the targeted area to enhance blood flow, ease muscle stiffness, and support the relaxation of soft tissue. Users can operate the heat and TENS features independently or simultaneously, depending on the desired therapeutic outcome. The device is designed for short-term, intermittent use, typically for 15–60 minutes per session, and may be used several times daily as required. It is suitable for use on areas such as the lower abdomen, lower back, shoulders, where muscular pain, menstrual cramps, or tension-related discomfort are commonly experienced. The Mendie device is intended for use by adults in home, wellness, or clinical settings under the direction of a healthcare professional, or for self-care following professional advice. It is not intended to diagnose, treat, cure, or prevent disease, and it should not be used as a substitute for medical attention in acute or undiagnosed pain conditions. The Mendie system comprises the main device unit with integrated heat and TENS functionality, reusable gel electrode pads, a USB charging cable, and an instruction manual.