The AtlasBIOvib is not FDA approved and not classified as a medical device. The AtlasBIOvib is meant for self-use only and is not meant to be used on others. The AtlasBIOvib is not intended to diagnose, treat, or prevent any diseases. If you are pregnant or have any medical conditions, please consult your physician before using the AtlasBIOvib. The AtlasBIOvib is only intended to be used as instructed in the User Manual.