Medical Devices; Physical Medicine Devices; Classification of the Nonpowered Lower Extremity Pressure Wrap
Information
Type
Rule
Regulated products
Medical Devices
Published
July 3, 2014
Last updated
July 3, 2014
Description
Document number 2014-15626. The Food and Drug Administration (FDA) is classifying the nonpowered lower extremity pressure wrap into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)