For A Healthy Life:
Movement is Everything®
Drs Marvin Sackner and Jose Adams, through research beginning 18 years ago and continuing to the present day, sensed an opportunity to introduce an innovative wellness device into the healthcare system.
As they saw it, such technology should be portable, low cost, effortless to use, capable of safe, self-administration in the home or workplace, and reduce risk and hold in check chronic, non-communicable diseases and conditions. Such new, innovative, wellness technology should address an obvious but difficult to remedy unhealthy component of lifestyle, physical inactivity. They formed Sackner Wellness Products LLC in late 2012 to design and market a low cost, portable, motorized device based upon effortless, rapid tapping the feet strapped to pedals against a semi-rigid bumper analogous to striking the ground during locomotion by controlling pedal speed. This device received a US Patent, Passive Simulated Jogging Device in 2017 and has been approved for patents in foreign countries as well.
With total medical expenditures approaching 20 percent of gross domestic product and suppressing other priorities of national importance owing to increasingly expensive prescription drugs, development and marketing of low cost, wellness devices targeted to non-communicable diseases that account for about 70% of deaths worldwide have potential to make a major socioeconomic impact. The current high and increasing costs of prescription drugs-coupled with the broader trends in overall health care costs is unsustainable to society.
FDA addressed this issue in a draft document first issued in January 2015 and finalized as a guidance document in July 2016. The document is entitled, General Wellness: Policy for Low Risk Devices. FDA defined a general wellness product, (1) as having an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition. Further, FDA decided not to regulate low-risk, noninvasive, wellness devices.
FDA also recommended intended uses for wellness devices that related to sustaining or offering general improvement to functions associated with a general state of health while making reference to diseases or conditions comprising two subcategories. 1) intended uses to promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions; and 2) intended uses to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.
FDA indicated that both subcategories of disease-related general wellness claims should only be based on references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition. That is, the claim that the healthy lifestyle choice(s) may play an important role in health outcomes should be generally accepted; such associations are described in peer-reviewed scientific publications or official statements made by healthcare professional organizations. Examples of chronic diseases for which a healthy lifestyle is associated with risk reduction or help in living well with that disease include heart disease, high blood pressure, and type 2 diabetes.
Sackner Wellness Products have been designed to adhere to the aforementioned recommendations.