Encision, Inc. - December 11, 2009
Issue Date
Dec 11, 2009
Region
Southwest
Category
Device
$117.00
Address 1
6797 Winchester Circle
City
Boulder
State
CO
Zip/Postal Code
80301-3513
Country
US
Inspection Range
Nov 23, 2009 - Dec 11, 2009
Pages
5
First Observation
Design validation did not ensure that devices conform to defined user/patient needs and intended uses.
Investigator(s): Thai Duong and Kimetha F. King