Reduce Pain Detoxify Speed Recovery Rejuvenate Stress Relief Introducing the FDA Approved Thermo-Therapeutic Far-Infrared Amethyst BioMat™ Unique treatment combination Far Infrared + Negative Ions “Stimulates the healing and regeneration of cells, nerves and meridians hidden beneath surface, adipose (fat) and muscle tissue layers.” Prescribed by Doctors for Chronic Pain caused by injuries, chronic fatigue, arthritis, muscle strain and more…. Seen to be effective for: Chronic Pain Depression Migraines Candida Detoxification Hypnotherapy Insomnia Arthritis Rejuvenation Lymphatic Stimulation Deep Mind/Body Relaxation Metabolic Support………..more [email protected] Unique Combination of Three Bio-Compatible Energy Therapies Far Infrared: Though it is invisible to the human eye approximately 80% of the sun's rays fall into the far infrared range. It is simply a form of energy that is directly transmitted into objects because of its specific wavelength. First discovered by NASA, scientists propose it is the most beneficial electromagnetic energy available for the human body, directly affecting all metabolic and cellular functions. Negative Ion: The key players in creating the electric energy within our body are structures called ions. Cells create electrical energy as ions move from the solutions inside the cells of our body to the solutions outside the cells. This becomes the energy source that initiates body functions ranging from muscle contraction to creative thought. Amethyst Crystal: are natural conductors of Far Infrared energy and create a refraction of the Far Infrared rays that enhances the bioavailability allowing for deeper penetration : 6-8 inches [email protected] Benefits of Therapies _______________________________________________________________________________________________________________________________________ Ease Muscle Pain & Stiffness of Joints Diminishing Inflammation Far- Infrared ray heat therapy is widely used to treat patients suffering from many forms of arthritis. In addition, it has been proven effective in the treatment of sprains, neuralgia, bursitis, muscle spasms, joint stiffness and many other muscular-skeletal ailments. _____________________________________________________________________________ Supports Detoxification By Stimulating the Lymphatic System & Cellular Metabolism Increased blood circulation and the opening of the ionic channels in the cells, stimulates the release of built-up toxins and waste. Daily sweating can help detoxify your body as it rids itself of an accumulation of potentially carcinogenic heavy metals, as well as alcohol, nicotine, sodium, sulfuric acid and cholesterol. Even without sweating, the deep penetration of the infrared rays supports the release of toxins that are then carried out of the body by the bowels, kidneys, skin and lungs. _____________________________________________________________________________ Reduces Stress & Fatigue Experience Deep States of Relaxation that Restore Health The combination of far infrared and negative ions treatments of the BioMat 7000mx quickly induces theta and delta brainwave states which are key to healing, regeneration and rejuvenation. During the delta state there is an increase in growth hormone levels, melatonin, immune function & reduced levels of cortisol in your body. The gentle warmth of the Far Infrared gives you an overall massaging effect, soothing jangled nerves and knotted muscles. You’ll feel rejuvenated and renewed, restored in both body and mind. [email protected] Shorten Injury Recovery Time Speeds up Cellular Regeneration The deep far Infrared heat of the Amethyst BioMat helps peripheral blood vessels dilate, bringing relief and healing to muscle and soft tissue injuries. Increased blood circulation carries off metabolic waste products and delivers oxygen-rich blood to oxygen-depleted muscles, so they recover faster. Speeds up cellular metabolic processes: – stimulating the activity of mitochondria – triggering enzyme activity – healing, regeneration, and normalization of damaged cell tissue _____________________________________________________________________________ Hyperthermia Strengthens Immune System - Supports Anti- Cancer programs When you heat the body with thermotherapy Heat Shock Proteins are created whose basic function is to protect our body from stress and repair damaged cells. In addition, heat shock proteins activate lymphocytes called natural killer cells and promote the synthesis of anti-cancer interferon to strengthen the body’s immune system. Our immune functions are improved by 40% when we increase our body temperature by only 1°. “Materials emitting far-infrared energy appear capable of increasing the functional power of white blood cells. These include increased immune defense response in which white blood cells surround and ingest small living things (such as bacteria) and cell wastes”.¹ ¹ (The International Journal of Biometeorology, 1993; Niwa Institute for Immunology in Tosashimizu, Japan ) [email protected] Strengthens Cardiovascular Function By Increasing Blood Circulation Increases peripheral blood flow and volume, resulting in improved circulation and heart function. FIR also activates enzymes that stimulate the production of Nitric Oxide a key biological messenger, playing a role in a variety of biological processes. These include blood vessel dilatation, neurotransmission “The more nitric oxide produced in the arteries, the more the muscles of the blood vessels relax and increase in diameter. Blood pressure also normalizes in the process.” _____________________________________________________________________________ Rebalances the Nervous System Supports Alkalization of Body The Negative Ions are delivered directly to the body through the skin’s surface via a bio-compatible, slow direct current of negative potential. This direct conduction of negative ions allows for an immediate response and change in the body’s electrical field for 100% of users. Negative ions control the balance of the sympathetic and parasympathetic nervous systems affecting heart rhythm, bronchial contractions, gastric peristalsis and secretions, bile flow, bladder contractions, etc. _____________________________________________________________________________ Increase Flexibility Improve Range of Motion Tissues heated to 45 C exhibit an increase of length in tissue when stretched. __* This effect would be especially valuable in working with ligaments, joint capsules, tendons, fascia and synovium that have become scarred, thickened or contracted __* Such stretching at 45 C caused much less weakening in stretched tissues than a similar stretching at normal temperatures. This safer stretching effect is crucial in properly training competitive athletes so as to minimize their “down” time from injuries. _____________________________________________________________________________________________________________________________________ “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. This device does not cure cancer. It does not prescribe any diagnosis or treatment and only claims the statements in the medical device listing of the FDA’s regulations. Specific medical advice should be obtained from a licensed health care practitioner. Any information and personal testimonies about this device do not reflect any medical claims.” [email protected] Medical Device used by Professionals The BioMat 7000 MX is an FDA registered Medical Device The BioMat is a US FDA 510k approved medical device for pain and stress management. It took RichWay five years and the ability to pass numerous safety and performance tests to reach this status. Establishment Registration Number: 2954299 The BioMat 2000 MX is being prescribed by Chiropractors, Naturopathic Doctors, Medical Doctors, Orthopedic Doctors, etc. for the following conditions: Chronic pain Lower Back and Leg Pain Chronic Pain of Neck and Back Pelvic, Scapula and Compression Fractures Cervio Lumbar Strain due to MVA Depression Muscle Strain Fibromyalgia Lumbar Sprain Insomnia Multiple Sclerosis Chronic Fatigue These prescriptions are being paid for by US. Medical Insurance Companies such as Kaiser Permanente, Ward North America, CNA, State Farm Insurance. US FDA 510K No: K072534 FDA Certification 510 (k) status (that states in part): The Bio-Mat is indicated for: Temporary relief of o joint pain associate with arthritis o muscle spasms o minor muscle pain o minor joint pain and stiffness o minor sprains and strains, o minor muscular back pain Relaxation of muscles Temporary increase of local circulation where applied [email protected] US Billing Codes: FDA Medical Device Est.Number: 2954299 510K No: K072534 BioMat FDA Medical Device Code 890.5740 Part # 943277834 Chiro/Physical Therapy Billing Code: 97026- Infrared CPT Code: 22852-8 Non-Participating Provider Number: 22852-8 HCPCS Code: E0221 - Infrared heating pad system Medicare: L27044 - Infrared Heating Pad Systems For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e. “reasonable and necessary”). Infrared Heating Pad Systems are considered for coverage under the Durable Medical Equipment benefit (Social Security Act §1861(s)(6)); however, the CMS National Coverage Determination 270.6 precludes payment for these items (see Infrared Heating Pad Systems Local Coverage Determination). In order for a beneficiary’s equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met ABC Code Set- EAAAJ - Cervical pillow therapeutic each item, Miscellaneous materials and/or supplies, Materials and/or supplies, Physical resources [email protected] Trusted Regulatory Standards The Bio-Mat™ Amethyst is certified by the following regulators US FDA Medical Device: ERN : 2954299 (Product Code 891-RT) The US. Food and Drug Administration is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. HCPCS listing: E0210 The Healthcare Common Procedure Coding System (HCPCS) was established in 1978 to provide a standardized coding system for describing the specific items and services provided in the delivery of health care. Such coding is necessary for Medicare, Medicaid, and other health insurance programs to ensure that insurance claims are processed in an orderly and consistent manner. Initially, use of the codes was voluntary, but with the implementation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) use of the HCPCS for transactions involving health care information became mandatory. It is the standard HIPAA code set for reporting supplies, orthotic and prosthetic devices, and durable medical equipment. In combination with the Current Procedure Terminology (CPT) codes, it is also used to report physician and other health care services. ISO 13485: Medical Device Manufacturer - 08 0037 SJ ISO 90001: Electrical Equipment Manufacturer – SKN1 454/94740 Conformity to International Standards helps reassure consumers that products are safe, efficient and good for the environment. It meets the requirements for a comprehensive quality management system for the design and manufacture of medical devices. ISO 13485 is now considered to be inline standard and requirement for medical devices. CE Approval: Eui-Si-2009-0555 CE marking means that the product conforms with as many EC directives as apply to the product. For example, most electrical or electronic products must comply with the Low Voltage Directive and the EMC Directive. It means that the manufacturer has verified that the product complies with all relevant essential requirements (such as safety, health, environmental protection requirements) of the applicable directive(s) or, if stipulated in the directive(s), has had it examined by a notified conformity assessment body GMP: No. 05-794 Good Manufacturing Practices is a production and testing practice that helps to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation [email protected] Safety & Standards The BioMat™ has received approval by many international safety panels. [email protected] Products Total Pro BioMat 7000mx Treatment System BioMat 7000mx Professional & Amethyst/Tourmaline Bio Pillow Item#1101 Size: 700 X 1880mm /27.56″ X 74″ Net Weight: 13kg / 28lb without Controller Electric Consumption: 160 W Voltage: AC 120 (North American) Temperature: 35ºC – 70ºC / 95ºF – 158ºF Item# 301A + Amethyst/ Tourmaline Bio Pillow Size: 480 X 300 X 120mm / 19″ X 12″ X 4.3″ Net Weight: 2.7kg / 6lb Amethyst Weight: 0.7kg Tourmaline Weight: 0.4kg This is the complete head to toe portable treatment system that fits a massage table and gives a safe, effective treatment in 30 minutes. o It can also be used overnight on low settings or for 1 hour detoxification sessions on the high sauna level settings. There are 8 different temp, settings to choose from. o It comes with a wheeled travel case and 100% cotton removable quilted pad [email protected] BioMat™ 7000mx Amethyst Professional Measures: (31.91"w x 77.81"h) Electric Consumption: 160w Temperature: 35c to 70c / 95f to 158f This mat comes in a massage-table size for all-purpose functionality and ease of mobility. Great tool for massage therapists, chiropractors or individual who works in a Health-related field. It comes with a travel case and 100% cotton padded cover. Item#1101 ______________________________________________________________________________________________________________________________________ BioMat™ 7000mx Amethyst Single Measures: 35.43"w x 77.81"h. Fits nicely on a twin bed. Electric Consumption: 180w Temperature: 35c to 70c / 95f to 158f Item # 101A --------------------------------------------------BioMat™ 7000mx Amethyst Queen Measures: 55.11"w x 77.81"h. Electric Consumption: 330w Temperature: 35c to 70c / 95f to 158f Comes with dual control to adjust settings on each side separately. Item # 102A [email protected] BioMat™ 7000mx Amethyst Mini-Mat Measures: 20"w x 34"h. Electrical consumption: 100w. Temperature 35c to 70c / 95f to 158f Perfect for offices or salons anywhere a contoured shape is needed. Buy a converter and use it while driving for a soothing ride. Item# 201 BioMat™ mx Amethyst and Tourmaline Pillow Developed for NASA this space-age Elastic memory foam conforms to your head and neck to ensure an anatomically supportive sleep posture. Features a therapeutic shape to provide additional support for your neck while comfortably cradling your head. Keeps your head cool while your body gets hot, and allows the healing properties of the Amethyst crystals to calm and relax your mind. . Considered a must according to Eastern Medicine. Includes a luxurious cotton zip cover for easy cleaning Item# 301A BioMat Waterproof Cover Protects your BioMat™ from sweat, oils, etc. without blocking beneficial energies. Professional - Item# 1101W Mini Item# 201W Quantum Energy Pad Enhances far infrared & negative ion therapies with added comfort especially for overnight use # 7040 - King: 21.20 lbs / 78.74″ x 70.86″ x 1.57″ # 7030 - Queen: 17.5lbs / 78.74″ x 59.06″ x 1.57″ # 7020 - Single: 11 lbs / 78.74″ x 39.37″ x 1.57″ # 7010 - Professional: 10 lbs / 72.83″ x 27.56″ x 1.57″ [email protected]
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