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Bayer introduces OTC back pain device

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German multinational pharmaeuutical company has a drug-free, device for fhe management of pain.
The device, Aleve Direct Therapy, uses transcutaneous electrical nerve stimulation (TENS), which delivers stimulating pulses to the pain site. TENS is typically used by doctors to help relieve lower back pain.
No prescription is needed for the device, which can be used for temporary relief of muscular pain in the lower back due to strain, exercise or even normal day-to-day activities.
According to Bayer’s announcement, the theory behind the therapy is that it blocks pain signals and in turn releases endorphins in the affected area.The device is operated with a wireless remote that controls the waveform technology.
The company says the device can be worn discreetly throughout the day and during some physical activities. Users go through a three-stage therapy session that can be repeated as necessary, with 30-minute breaks between sessions.
The first stage, during which high-frequency stimulation first initiates pain suppression, lasts 5 minutes. A 20-minute second stage offers low-frequency stimulation to increase the release of endorphins. The final stage lasts an additional 5 minutes and offers the same high-frequency stimulation as stage one, to maintain the feeling of pain relief.
“Aleve Direct Therapy puts controllable TENS technology in consumers’ hands without having to visit the doctor,” said Andre Schmidt, vice president of U.S. medical affairs for Bayer’s consumer health division, in the announcement.
“It provides high intensity of power and its wireless remote control makes it easy to adjust the power of intensity to fit the user’s needs.” The device is regulated as a Class II medical device and was cleared by the FDA.

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