Type 2 Diabetic Management
Application of Gentle Jogger in Type 2 Diabetic Management
Reduces blood glucose variability.
Trend to normalization of glucose tolerance test.
Decreases insulin resistance associated with prolonged, uninterrupted, sitting or lying down.
Increases heart rate variability.
FDA General Wellness Policy for Low Risk Devices
General wellness products are those that (1) are intended for only general wellness use, and (2) present a low risk to the safety of users and other persons. These products will not be regulated by FDA
Products involve claims about sustaining or offering general improvement to functions associated with a general state of health that do not make any reference to diseases or conditions. This first category of general wellness claims as relating to the Gentle Jogger® include among others improved physical fitness, mental acuity and mobility.
Involve claims relating to sustaining or offering general improvement to functions associated with a general state of health while making reference to diseases or conditions as listed below.
- 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
- intended uses to promote, track, and/or encourage choice(s) which, as part of healthy lifestyle, may help living well with certain chronic diseases or conditions.
- 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.