Yes, Meditech Fetal Dopplers are manufactured by industry leaders which meets meet the standards. They have been approved by ISO13485 and have passed CE Certificates. They are approved for personal use at home and do not require a prescription. The waves emitted by a fetal doppler are far lower than those put out by an ultrasound (sonogram) machine and use probes at a much lower frequency. As always with any questions regarding your pregnancy, if you have any concerns about the safety of Fetal Dopplers we suggest you consult with your healthcare provider.