Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs
fda-device · Food and Drug Administration · Rule · Published 2014-04-14 · Effective 2014-04-14 · 79 FR 20779
Document
Document number
2014-08257
Federal Register citation
79 FR 20779
CFR reference
21 CFR 890
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-04-14
Effective date
2014-04-14
HHS docket
Docket No. FDA-2013-N-0568
Abstract
The Food and Drug Administration (FDA) is issuing a final 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 further clarify the identification.