Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs
Information
Type
Proposed Rule
Regulated products
Published
June 12, 2013
Last updated
June 12, 2013
Description
Document number 2013-13864. The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify stair-climbing wheelchairs, a class III device, into class II (special controls) based on new information and subject to premarket notification, and to further clarify the identification.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)