Final answer:
A mobile app analyzing EKG waveforms for heart irregularities is classified as a Medical device by the FDA, falling under regulations for Mobile Medical Applications.
Step-by-step explanation:
According to FDA guidance, a mobile app running on a smart phone to analyze and interpret EKG waveforms to detect heart function irregularities is considered a Medical device.
The use of such a mobile app falls under the regulation for Mobile Medical Applications as it performs a critical function of diagnosing or treating diseases by transforming a mobile platform into a regulated medical device.
Technological advancements have allowed ECG technology to advance to the point where portable ECG monitors can be incorporated into wearable devices and mobile apps, facilitating real-time cardiac monitoring and analysis. Due to these functionalities, the correct answer is A. Medical device.