Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid Prevention Pressure Wedge
Information
Type
Rule
Regulated products
Medical Devices
Published
April 15, 2011
Last updated
April 15, 2011
Description
Document number 2011-9141. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)