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    FDA Approves Wireless Wearable Electrotherapy Device for Back Pain

    The U.S. Food and Drug Administration has approved over-the-counter sale of the Hollywog WiTouch device, targeting back pain. The WiTouch Pro model, with advanced features, is available with a doctor’s prescription.

    The WiTouch device offers a drug-free solution for lower back pain. The wearable device with replaceable gel pads is flexible and discreet.

    The lightweight product utilizes Transcutaneous Electrical Nerve Stimulation (TENS) to target pain. The wireless therapeutic device stimulates the area’s nerves and muscle fibers. Relief can be felt immediately and several hours after use, according to the startup. The WiTouch may be worn as long as needed.

    Now Available for sale at www.4mdmedical.com

    Hollywog WiTouch is the first wireless remote controlled pain relief device incorporating TENS technology to specifically target lower back pain. The thin and flexible design perfectly contours the back for a perfect fit on almost any body shape. Advanced electronics design maximizes energy use providing over 150 30-minute treatment sessions per battery life. This innovative device is safe, drug-free, easy to use, discreet & comfortable to wear, and most importantly allows you to control your pain to maintain an active lifestyle.

    • Wireless handheld remote control… control your pain the instant you need it!
    • Drug-Free with No Side Effects
    • Thin, flexible and discreet – wear under your clothing for hours of pain relief when you need it
    • So comfortable and lightweight, you forget you are even wearing it…no one ever knows who is wearing a WiTouch
    • No wires, bulky back wraps or belts
    • Easy to use, self-applicable and ready to use out of the box – no complicated programs and settings to learn or adjust
    • Over 150 30-minute treatments before changing batteries
    • As powerful as professional equipment – 20% higher intensity output than typical portable devices available today and 2.5 times larger treatment area coverage
    • Replaceable Gel Pads for multiple back pain relief applications

    ABOUT WITOUCH TENS

    1. What is TENS?

    TENS (Transcutaneous Electrical Nerve Stimulation) is a non-invasive, drug free method of controlling pain by the transmission of electrical stimulation to the body’s nerve or muscle fibers through the skin. Pain relief or supression is achieved by: Supressing the transmission of pain in nerves (Gate Control Theory) and increasing the discharge of the body’s endorphins, which reduces the sensivity to pain in the central nervous system (Opiate Release Theory). The Hollywog® WiTouch’s exclusive and patented waveform incorporates BOTH clinical theories of TENS to provide immediate and long-lasting pain relief. The Hollywog WiTouch provides a safe, easy to apply, medically approved pain management system for self-treatment when needed. The WITouch is perfect for those with chronic low back pain.

    2. How does TENS work to relieve pain?

    Pain relief or suppression is achieved by:
    Suppressing the transmission of pain in nerves (Gate Control Theory) and Increasing the discharge of the body’s endorphins, which reduces the sensitivity to pain in the central nervous system (Opiate Release Theory)

    3. How does the WiTouch provide pain relief?

    WiTouch’s exclusive and patented stimulation waveform incorporates BOTH clinical theories of TENS to provide pain relief. You may feel immediate relief as soon as you start the device, and you may feel pain relief as long as 3-4 hours after use.

    WITOUCH SAFETY AND USE

    4. Can I use WiTouch if I am pregnant?

    No. The safety of nerve stimulation has not been established during pregnancy; therefore do not use this device if you are pregnant, or suspect that you are pregnant

    5. How long can I wear my WiTouch?

    WiTouch can be worn all day. The device does not have to be removed between stimulation treatments.

    6. Can I use the WiTouch on another body area besides my back?

    No, WiTouch is designed specifically for the treatment of back pain. WiTouch was designed to specifically fit the back and will not fit other body areas to allow performance. WiTouch can be used on the lower back areas.

    7. Can I use the WiTouch in hot and humid conditions?

    Hot and humid conditions can affect the adhesion properties of the WiTouch gel pads, so care should be taken in such condi- tions. Heat and humidify will not affect the operation of the device.

    8. Can I wear my WiTouch while sleeping?

    No, WiTouch should not be worn while sleeping.

    9. Can I wear my WiTouch while driving?

    No, WiTouch should not be worn while driving, operating heavy machinery or any other activity in which electrical stimulation can put you at risk of injury.

    10. Can I use WiTouch when I am working?

    WiTouch can be worn at home or at the office, but it should not be worn in work settings in which heavy machin- ery is operated or any situation in which electrical stimulation can put you at risk of injury. WiTouch should not be worn during strenuous physical activity as this may affect the proper adhesion of the device.

    11. Can I share my WiTouch with someone else?

    WiTouch gel pads are single person use and should not be shared between people. The WiTouch device can be used by other people with proper cleaning of the device and new gel pads applied.

    WITOUCH OPERATION

    12. My WiTouch is not working when I press the remote.

    The main device is OFF and should be turned ON. If you receive yellow blinks on the remote when the START button is pressed, the remote control is not able to communicate with the device.
    Note the main unit automatically shuts OFF after 2 hours of inactivity.

    13. Why is the LED blinking yellow?

    Change your batteries. The blinking yellow indicates low battery.

    14. What if I lose my remote control?

    WiTouch cannot be operated without the remote control, so you will need to order a replacement remote control. WiTouch Pro can be operated without a remote control, so you can continue using the device.

    WITOUCH CARE & MAINTENANCE

    15. What kind of batteries does my WiTouch use?

    The WiTouch device uses 2 AAA batteries. The remote control uses 1 CR2032 lithium coin battery

    16. How often do I have to change the batteries in my WiTouch and remote?

    The 2 AAA batteries in the WiTouch device will last for approximately 150 treatments, depending on the intensity. The remote control CR2032 battery will last approximately 1 year.

    17. How do I clean my WiTouch?

    WiTouch should be gently wiped clean with a damp cloth and mild soap. All soap residue must be removed before use. DO NOT submerge or immerse the device in water or other liquids as it will damage the device.

    18. How do I store my WiTouch?

    WiTouch should be stored in the storage box included with your device. If the device is being stored for a short time between uses and the gel pads are still applied to the device, the green protective liners should be applied to the gel pads before storage. If the device will be stored for a long period of time, the 2 AAA batteries should be removed from the main device.

    19. What is the warranty on the WiTouch?

    The warranty is 1 year assuming normal wear and tear. (NOTE: WiTouch should not be submerged in water or worn while showering)

    WITOUCH GEL PAD INFORMATION

    20. Do I have to use the Gel pads?

    Yes, the WiTouch device can ONLY be used with the gel pads designed specifically for WiTouch. Attempted use of WiTouch without WiTouch Gel Pads can result in skin irritation or burns.

    21. Where can I get new gel pads?

    You can purchase new gel pads from the same retail outlet that you purchased your WiTouch device. You can also check your local chiropractor, DME or call Core Products Customer Service at 800-365-3047.

    22. Why are my gel pads not sticking?

    Gel pads will stick effectively for 3-5 applications on average. The number of applications depends on skin prepara- tion and skin type. Excessive oil, moisturizers and perspiration will affect the gel pads’ ability to adhere properly. You should always clean the treatment area with soap and water before applying your WiTouch to ensure optimal adhesion.

    23. How many times can I use the gel pads?

    The number of uses you can obtain from gel pads will vary, primarily due to skin preparation. Each time WiTouch is removed from the back, dead skin cells are removed adhered to the gel pads. Over time, the accumulation of this “skin cell debris” diminishes the gel pads’ ability to adhere. Insufficient skin preparation will also affect gel pad adhesion.

    24. How often do I replace the gel on my WiTouch?

    The gel should be replaced on your WiTouch when the adhesion diminishes. This will vary person to person and depending upon skin preparation, but 3-5 applications is typical.

    25. Why can I see some of the “black” from the WiTouch electrodes on my fingers?

    The black residue you may see on your fingers from handling the WiTouch device is from the conductive carbon element within the electrodes. The residue is normal and can be wiped away.

    Source http://mashable.com/2012/08/31/hollywog-witouch/

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