Medical Devices; Physical Medicine Devices; Classification of the Nonpowered Lower Extremity Pressure Wrap
fda-device · Food and Drug Administration · Rule · Published 2014-07-03 · Effective 2014-08-04 · 79 FR 37948
Document
Document number
2014-15626
Federal Register citation
79 FR 37948
CFR reference
21 CFR 890
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-07-03
Effective date
2014-08-04
HHS docket
Docket No. FDA-2014-M-0701
Abstract
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.