Cleared Traditional

K122485 - ENCIRCLE COMPRESSION THERAPY STOCKING
(FDA 510(k) Clearance)

K122485 · Encircle Medical Devices , Ltd. · General Hospital

Apr 2013

Decision

252d

Days

Class 2

Risk

K122485 is an FDA 510(k) clearance for the ENCIRCLE COMPRESSION THERAPY STOCKING. This device is classified as a Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (Class II — Special Controls, product code DWL).

Submitted by Encircle Medical Devices , Ltd. (Palos Verdes Estates, US). The FDA issued a Cleared decision on April 23, 2013, 252 days after receiving the submission on August 14, 2012.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5780.

Submission Details

510(k) Number	K122485 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 2012
Decision Date	April 23, 2013
Days to Decision	252 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	DWL — Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5780