The Heart Sound Recorder is a computer-based low risk general wellness monitor which uses the principles of auscultation to acquire, display, record and save heart sounds.
Certain types of heart stress can be monitored by visualizing the rate, rhythm and tone of the heart cycle. As a result, the heart’s reaction to certain stressors, i.e. chemical, nutritional and emotional, can be observed using this type of device. The response to informed suggestions can be monitored by observing changes of the frequency, ratio, amplitude and characteristics of the heart’s waveform. Comparison graphs can help determine the effectiveness of actions taken to improve the quality of life.
As a general wellness device it relates to a healthy lifestyle by 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. As such the intended use is to promote, track and/or encourage choice(s), which, a a part of a healthy lifestyle, may help reduce the risk of certain chronic diseases or conditions and may help with living well with certain chronic diseases or conditions.
The Heart Sound Recorder is a low risk* non-invasive device that is not implanted and does not involve a technology that may pose a risk to the safety of users or other persons if specific regulatory controls are not applied (such as risks from lasers or radiation exposure).
*as defined by the document issued July 29, 2016, General Wellness: Policy for Low Risk Devices; Guidance for Industry and Food and Drug Administration Staff