title: Medical devices; obstetrical and gynecological devices; classification of the hemorrhoid prevention pressure wedge. Final rule.
abstract: The Food and Drug Administration (FDA) is classifying the hemorrhoid prevention pressure wedge into class II (special controls). The special controls will apply to the device in order to provide a reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge provides support to the perianal region during the labor and delivery process.
mesh_terms: D036861:Delivery, Obstetric / Q000295:instrumentation*; D004869:Equipment Safety / Q000145:classification* / Q000295:instrumentation; D005260:Female; D006484:Hemorrhoids / Q000517:prevention & control*; D006801:Humans; D007743:Labor, Obstetric; D009774:Obstetrics / Q000295:instrumentation*; D011247:Pregnancy; D011312:Pressure