{"product_id":"bone-growth-stimulator","title":"Bone Growth Stimulator","description":"\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e*Doctor prescription is needed from a Podiatrist, Orthopedic Surgeon or Spine Specialist, whether to process through health insurance plans or out-of-pocket self pay.\u003c\/p\u003e\n\u003cp\u003eCMF OL1000\u003c\/p\u003e\n\u003cp\u003eBone Growth Stimulators are portable, battery-powered medical devices indicated for use in the noninvasive treatment of an established nonunion fracture acquired secondary to trauma, excluding all vertebrae and flat bones. The device was designed with following features:\u003c\/p\u003e\n\u003cul class=\"tight\"\u003e\n\u003cli\u003eLightweight and comfortable\u003c\/li\u003e\n\u003cli\u003eEasy-to-use \u0026amp; Noninvasive\u003c\/li\u003e\n\u003cli\u003eRequires simple, one-button operation\u003c\/li\u003e\n\u003cli\u003eDevice is worn for 30 minutes per day\u003c\/li\u003e\n\u003cli\u003eCan be used with internal or external fixation or over a cast\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eThis treatment has been shown in pre-clinical studies to help the body’s own healing process begin working. Clinical studies reported success rates as high as 89%.\u003csup\u003e6\u003c\/sup\u003e\u003c\/p\u003e\n\u003cp class=\"large\"\u003e\u003cem\u003ePublished April 2021: New study observed significant cost savings with use of OL1000 vs. surgical intervention. \u003ca href=\"https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/14737167.2021.1920402\"\u003eView Study Results\u003c\/a\u003e.\u003c\/em\u003e\u003c\/p\u003e\n\u003cp class=\"large\"\u003e \u003c\/p\u003e\n\u003cdiv class=\"row use-flex\"\u003e\n\u003cdiv class=\"col-sm-12 col-xs-12 text-center padding-bottom-2\"\u003e\n\u003ch4 class=\"large all-caps\"\u003eDESIGNED WITH PATIENT COMFORT IN MIND\u003c\/h4\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"row use-flex\"\u003e\n\u003cdiv class=\"col-sm-4 col-xs-6 text-center\"\u003e\n\u003cdiv class=\"padding-1\"\u003e\n\u003cimg height=\"98\" width=\"98\" class=\"diplay-block gutter-bottom max-width-1\" src=\"https:\/\/enovis.widen.net\/content\/vleboyypib\/svg\/icon-feather.svg?u=rewuhh\" alt=\"icon-feather.svg\"\u003e\n\u003ch4 class=\"font-weight-1 text-color-black\"\u003eLightweight device with custom strap for maximum patient comfort\u003c\/h4\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"col-sm-4 col-xs-6 text-center\"\u003e\n\u003cdiv class=\"padding-1\"\u003e\n\u003cimg height=\"89\" width=\"89\" class=\"diplay-block gutter-bottom max-width-1\" src=\"https:\/\/enovis.widen.net\/content\/pnoggux9qp\/svg\/icon-polo-shirt.svg?u=rewuhh\" alt=\"icon-polo-shirt.svg\"\u003e\n\u003ch4 class=\"font-weight-1 text-color-black\"\u003eCan be applied over a brace or clothing\u003c\/h4\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"col-sm-4 col-xs-6 text-center\"\u003e\n\u003cdiv class=\"padding-1\"\u003e\n\u003cimg height=\"90\" width=\"90\" class=\"diplay-block gutter-bottom max-width-1\" src=\"https:\/\/enovis.widen.net\/content\/lxkufrstjo\/svg\/icon-data-analysis.svg?u=rewuhh\" alt=\"icon-data-analysis.svg\"\u003e\n\u003ch4 class=\"font-weight-1 text-color-black\"\u003eBuilt in compliance tracking\u003c\/h4\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"col-sm-4 col-xs-6 text-center\"\u003e\n\u003cdiv class=\"padding-1\"\u003e\n\u003cimg height=\"96\" width=\"96\" class=\"diplay-block gutter-bottom max-width-1\" src=\"https:\/\/enovis.widen.net\/content\/ddtdeej29u\/svg\/icon-power-button.svg?u=rewuhh\" alt=\"icon-power-button.svg\"\u003e\n\u003ch4 class=\"font-weight-1 text-color-black\"\u003eOne button technology for ease of use\u003c\/h4\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"col-sm-4 col-xs-6 text-center\"\u003e\n\u003cdiv class=\"padding-1\"\u003e\n\u003cimg height=\"101\" width=\"101\" class=\"diplay-block gutter-bottom max-width-1\" src=\"https:\/\/enovis.widen.net\/content\/dkahn6d9dw\/svg\/icon-support-phone.svg?u=rewuhh\" alt=\"icon-support-phone.svg\"\u003e\n\u003ch4 class=\"font-weight-1 text-color-black\"\u003eExperienced customer service support team available to all patients\u003c\/h4\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"col-sm-4 col-xs-6 text-center\"\u003e\n\u003cdiv class=\"padding-1\"\u003e\n\u003cimg height=\"105\" width=\"105\" class=\"diplay-block gutter-bottom max-width-1\" src=\"https:\/\/enovis.widen.net\/content\/0cadfxaoe8\/svg\/icon-team.svg?u=rewuhh\" alt=\"icon-team.svg\"\u003e\n\u003ch4 class=\"font-weight-1 text-color-black\"\u003ePersonalized service by highly trained account representatives available to size, fit and train patients\u003c\/h4\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cul data-processed=\"true\" data-complete=\"true\" class=\"KsbFXc U6u95\"\u003e\n\u003cli data-sae=\"\" data-complete=\"true\" data-hveid=\"CAQQAA\"\u003e\u003cspan data-complete=\"true\" data-sfc-cp=\"\" class=\"T286Pc\"\u003e\u003cstrong data-complete=\"true\" class=\"Yjhzub\"\u003eFederal Regulation:\u003c\/strong\u003e Under \u003cspan data-complete=\"true\" data-sfc-cp=\"\"\u003e\u003ca href=\"https:\/\/www.google.com\/url?sa=i\u0026amp;source=web\u0026amp;rct=j\u0026amp;url=https:\/\/blog.elitemedicalsupply.com\/bone-growth-stimulator-therapy\u0026amp;ved=2ahUKEwiq8Y6Uyt6SAxXB4ckDHW0XF7EQy_kOegQIBBAB\u0026amp;opi=89978449\u0026amp;cd\u0026amp;psig=AOvVaw3TPOpXRmkDyra5-M3fmNgY\u0026amp;ust=1771350819281000\" data-hveid=\"CAQQAQ\" rel=\"noopener noreferrer\" class=\"H23r4e\" target=\"_blank\"\u003e21 CFR 801.109\u003c\/a\u003e\u003c\/span\u003e\u003cspan data-complete=\"true\" data-sfc-cp=\"\" class=\"T286Pc\"\u003e, the \u003cspan data-complete=\"true\" data-sfc-cp=\"\" class=\"T286Pc\"\u003eFDA\u003c\/span\u003e classifies all bone growth stimulators as \"prescription-use only\" devices\u003c\/span\u003e.\u003c\/span\u003e\u003c\/li\u003e\n\u003cli data-sae=\"\" data-complete=\"true\" data-hveid=\"CAQQAg\"\u003e\u003cspan data-complete=\"true\" data-sfc-cp=\"\" class=\"T286Pc\"\u003e\u003cstrong data-complete=\"true\" class=\"Yjhzub\"\u003eFlorida Law:\u003c\/strong\u003e Florida state rules (such as \u003cspan data-complete=\"true\" data-sfc-cp=\"\"\u003e\u003ca href=\"https:\/\/www.google.com\/url?sa=i\u0026amp;source=web\u0026amp;rct=j\u0026amp;url=https:\/\/floridasoccupationaltherapy.gov\/florida-administrative-code-rule-64b11-4-001-use-of-prescription-devices\/\u0026amp;ved=2ahUKEwiq8Y6Uyt6SAxXB4ckDHW0XF7EQy_kOegQIBBAD\u0026amp;opi=89978449\u0026amp;cd\u0026amp;psig=AOvVaw3TPOpXRmkDyra5-M3fmNgY\u0026amp;ust=1771350819281000\" data-hveid=\"CAQQAw\" rel=\"noopener noreferrer\" class=\"H23r4e\" target=\"_blank\"\u003eRule 64B11-4.001\u003c\/a\u003e\u003c\/span\u003e) strictly govern the use of prescription devices, and medical providers in Florida cannot legally dispense these units without a valid order from a licensed practitioner.\u003c\/span\u003e\u003c\/li\u003e\n\u003cli data-sae=\"\" data-complete=\"true\" data-hveid=\"CAQQBA\"\u003e\n\u003cspan data-complete=\"true\" data-sfc-cp=\"\" class=\"T286Pc\"\u003e\u003cstrong data-complete=\"true\" class=\"Yjhzub\"\u003eInsurance Coverage:\u003c\/strong\u003e Most insurers, including \u003cspan data-complete=\"true\" data-sfc-cp=\"\" class=\"T286Pc\"\u003eMedicare\u003c\/span\u003e and private health plans in Florida, only cover the cost if the device is deemed \"medically necessary\" and prescribed by an orthopedic surgeon or spine specialist.\u003c\/span\u003e\n\u003cdiv data-complete=\"true\" data-ved=\"2ahUKEwiq8Y6Uyt6SAxXB4ckDHW0XF7EQ3s0SegQIBBAG\" data-signal-inputs=\"scS1X=VedrQ_14\/scS1X\" data-animation-skip=\"\" class=\"Fwa2Od\"\u003e\n\u003cimg data-imgprocessed=\"true\" data-atf=\"1\" data-csiid=\"o1mTab_NDJ7Ip84P9fHjqQI_13\" data-aatf=\"1\" data-imglogged=\"true\" alt=\"Food and Drug Administration (.gov)\" src=\"data:image\/png;base64,iVBORw0KGgoAAAANSUhEUgAAACAAAAAgCAMAAABEpIrGAAAACVBMVEUAUJ+trKD\/\/\/+SRVNjAAAAT0lEQVQ4jWNgJAAYBoOCoQGYoADGQAjjUACVQFaAyoBQYA3YFUBo0hRALUZWAFNEpAIsVqD6B1MBio+xeRPdx6ghRkgBNlsHPRgMOYuQAgBGkQKJl8ZrlwAAAABJRU5ErkJggg==\" class=\"lXbsme\" id=\"img-o1mTaeqTEcHDp84P7a7ciAs_2\"\u003e \u003cspan class=\"wJwe6c\"\u003e\u003cspan class=\"iFMVXd\"\u003eFood and Drug Administration (.gov)\u003c\/span\u003e\u003cspan class=\"IjM6od\"\u003e +5\u003c\/span\u003e\u003c\/span\u003e\n\u003c\/div\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch4 class=\"gutter-bottom\"\u003eBrief Prescribing Information\u003c\/h4\u003e\n\u003cp class=\"font-weight-1\"\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e: Noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.\u003c\/p\u003e\n\u003cp class=\"font-weight-1\"\u003e\u003cstrong\u003eCONTRAINDICATIONS\u003c\/strong\u003e: Use of this device is contraindicated in individuals having a synovial pseudarthrosis. Demand-type pacemaker or implantable cardioverter defibrillator (ICD) operation may be adversely affected by exposure to magnetic fields. Physicians should not prescribe CMF 0L1000 for applications that may place the treatment transducers in close proximity to the pacemaker. Further screening by the attending cardiologist is recommended (such as with an electrocardiogram). CMF 0L1000 should not be used in the presence of external or internal fixation devices that are constructed from magnetic materials.\u003c\/p\u003e\n\u003cp class=\"font-weight-1\"\u003e(NOTE: Almost all fracture fixation devices implanted today are made from nonmagnetic materials.)\u003c\/p\u003e\n\u003cp class=\"font-weight-1\"\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e: The safety and effectiveness of the use of this device on individuals lacking skeletal maturity have not been established. Animal studies conducted to date do not suggest any long-term significant adverse effects from use of this device. However, long-term effects in humans are unknown. Teratological studies have not been performed with this device. The safety of use of this device during pregnancy or nursing in humans has not been established.\u003c\/p\u003e\n\u003cp class=\"font-weight-1\"\u003e\u003cstrong\u003ePRECAUTIONS\u003c\/strong\u003e: Weight bearing is not advised in the presence of extreme motion at the nonunion site. In the presence of a malaligned nonunion, careful consideration of the use of this device must be undertaken on an individual basis, as treatment with this device is not intended to alter or affect the degree of malalignment. The safety and effectiveness of the use of this device on individuals with nonunion secondary to, or in conjunction with, a pathological condition have not been established. This device should not be used if there are mental or physical conditions that preclude patient compliance with the physician and device instructions. When conditions of atrophy are present or when fractures have remained unhealed for long periods of time, there may be less successful results.\u003c\/p\u003e\n\u003cp class=\"font-weight-1\"\u003e\u003cstrong\u003eADVERSE EFFECTS\u003c\/strong\u003e: No known significant adverse effects have resulted from the use of this device. Clinical studies, animal studies, and tissue culture experiments conducted with the OL1000, which has the same treatment signal as the OL1000 SC1, have not indicated any evidence of significant adverse effects.\u003c\/p\u003e\n\u003cp class=\"font-weight-1\"\u003e\u003cstrong\u003eCAUTION\u003c\/strong\u003e: Federal law (U.S.A. and Canada) restricts this device to sale, distribution or use by or on the order of a physician.\u003c\/p\u003e","brand":"OrthoSTAT","offers":[{"title":"CMF OL1000 Dual Coil","offer_id":56200156184742,"sku":"01-203-0001","price":2995.0,"currency_code":"USD","in_stock":true},{"title":"CMF OL1000 Dual Coil Size 1","offer_id":56200156217510,"sku":"01-211-0001","price":2995.0,"currency_code":"USD","in_stock":true},{"title":"CMF OL1000 Dual Coil Size 2","offer_id":56200156250278,"sku":"01-211-0003","price":2995.0,"currency_code":"USD","in_stock":true},{"title":"CMF OL1000 Dual Coil Size 3","offer_id":56200156283046,"sku":"01-211-0003","price":2995.0,"currency_code":"USD","in_stock":true},{"title":"CMF OL1000 Dual Coil Size 4","offer_id":56200156315814,"sku":"01-211-0004","price":2995.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0462\/8558\/6598\/files\/C747C4BE-0F86-40F7-90D8-6AE0B876232F.jpg?v=1771262683","url":"https:\/\/orthostatmedicalsupply.com\/products\/bone-growth-stimulator","provider":"OrthoSTAT","version":"1.0","type":"link"}