510(k) K122485

ENCIRCLE COMPRESSION THERAPY STOCKING by Encircle Medical Devices , Ltd. — Product Code DWL

K122485 is an FDA 510(k) premarket notification submitted by Encircle Medical Devices , Ltd. for the device "ENCIRCLE COMPRESSION THERAPY STOCKING". The FDA issued a decision of Substantially Equivalent on April 23, 2013. The device falls under product code DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)), a Class II device regulated under 21 CFR 880.5780.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2013
Date Received
August 14, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Device Class
Class II
Regulation Number
880.5780
Review Panel
HO
Submission Type