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The FDA has classified the FIR Mat as a Class II Medical Device.
The FDA classifies medical devices based on the risks associated with the device. Devices are classified into one of three categories: Class I, Class II, and Class III.Class I devices are deemed to be low risk, and are, therefore, subject to the fewest regulatory controls. For example, dental floss is classified as a Class I device.Class II devices are higher risk devices than Class I, and require more regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. For example, condoms are classified as Class II devices.Class III devices are generally the highest risk devices, and are, therefore, subject to the highest level of regulatory control. Class III devices must typically be approved by FDA before they are marketed. For example, replacement heart valves are classified as Class III devices.
Our manufacture most certainly does. What this means is the ” FDA does not ‘approve’ health care facilities, laboratories, or manufacturers. FDA does inspect product manufacturers to verify that they comply with good manufacturing practices. “Additionally, internal quality control is very stringent. Approximately five percent of all far infrared mats produced are grueling checked.
There is no simpler way of acquiring improved health than sleeping or sitting on a far infrared mat. The body is designed to heal itself, and it does a really great job of it when we give it what it needs. But, with our busy lifestyles, it is not always possible to exercise regularly and prepare the best food. How many restaurants serve organic/non-GMO meals? Only a few of the juice bars are serving organic. So, how do you improve your health when you have a busy schedule? You can start by sleeping on an amethyst mat, or simply put it over the back of your chair while you work. It takes zero time out of your schedule, and your body will love you for it.
Both negative ions and infrared heat go into the body through the thick layer of natural amethyst or amethyst and tourmaline crystals covering the surface of the mat’s construction. Amethyst and tourmaline crystal refraction organizes the far infrared light and negative ions into patterns with the highest biocompatibility and healing effects. Whether you’re looking to relieve back pain, hip pain, shoulder pain, or pain from sciatica, far infrared will help by reducing the inflammation caused by these issues.
Additionally, when used at higher temperatures, far infrared therapy can create a false fever in the body with its deeply penetrating heat from four to six inches into the body. A fever stimulates the immune system into producing more white blood cells, antibodies, and a protein called interferon, all of which work to protect the body against harmful microorganisms. All animals use fevers to strengthen their immune systems when they are ill.
By definition, a fever is simply any elevated temperature that is higher than what is normal for you. Just a one- or two-degree increase can produce very healing effects. Fever also increases the metabolism. Amid all this activity, your circulation is increased, stimulating natural detoxification, thus increasing your metabolism. The deeply penetrating heat is very relaxing, soothes stressed muscles, and reduces pain and inflammation. The negative ions naturally generated by the amethyst are purported to produce a calming effect and help one get a good night’s sleep.
To connect the temperature controller to your mat, hold a plug in each hand and press together following the pattern on the plugs. Plug into the mat before you plug into the wall. It is a very tight fit, so push hard to ensure you push it all the way in. If it is not all the way in when you plug it into the wall, you will get an “E2” or “OF” on the controller display window. This means it is not fully connected.
To disconnect the controller from the mat, hold it firmly to each end of the plug. NEVER pull by the cord as the plugs fit tightly, and you risk damaging your cord.
CONTROLLER: Plug your mat in first and then plug it into the wall to activate the sensor. Turn your mat on and set it to the desired temperature by turning the dial. Your display will first show what you are setting the thermostat at and will then drop down to what the temperature actually is. Your controller is in Celsius. See the chart below for the conversion table. Then press the timer button to set the desired shut-off time till the desired option is shown in the display window, i.e., 1 hrs, 4 hrs, or 8 hrs. Each time you press the button, additional hours will be added, and your mat will turn off on schedule.
DIRECTIONS: If you have a sensitive body, you may want to gradually increase the length of time on your mat and/or temperature increases. Our mat produces zero electromagnetic field (EMF) emissions due to our multi-wire heating system protected by Teflon and copper netting, eliminating all EMF exposure. The Charmed or Radiant FIR Mat is typically used for 30-minute to 2-hour sessions while sitting in a chair, reading a book, watching TV, or just closing your eyes and relaxing before bed. The more you use it, the more benefit you will gain, but the choice is yours. You can sleep on the FIR Mat all night if you choose. Just keep it at a comfortable temperature for sleep without sweating. Protecting your mat is easy. We recommend when sleeping on your FIR mat, you put it underneath your mattress pad for additional cushioning. If using your mat elsewhere, cover it with a fluffy towel, which is easily washed. However, our mats are stain-resistant and will wipe off easily with a damp cloth.
Do not put your far infrared mat into water or use the device in wet or excessively humid areas.
Do not use the device when your hands and body are wet.
Do not heat the controller by placing it on your mat.
Do not use at high temperatures overnight.
Do not use above 95 -104°F (35 – 40°C) if you have piercings or any other metal on your body unless that part of your body is off the mat or is removed.
Do not use the device if you are the recipient of Titanium, Metal, Ceramic, Silicon, or Plastic surgical implants without checking with your physician before use.
Do not use it at high temperatures if you are pregnant. For the negative ion benefits, use only at lower temperatures.
Do not overuse this device at maximum temperature, as this may result in excessive stimulation. Use it moderately at a high temperature.
Do not keep your head on the heated portion of the amethyst mat for long periods of time. The bio pillow with amethyst, and no heating element, is strongly recommended.
Do not continue using your mat if it, or the controller, is damaged in any way.
Do increase water intake before and after sessions.
Do not allow yourself to get dehydrated.
Do start slowly at low settings and gradually increase duration and temperature to suit you personally.
Do contact a vet before using the device on your pet, and always supervise sessions.
Do hold both ends of the mat plug when extracting the cord.
Do not pull from the cord.