Cleared Traditional

TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET

K121106 · Surgical Appliance Industries, Inc. · General Hospital

Apr 2012

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K121106 is an FDA 510(k) clearance for the TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET, a Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (Class II — Special Controls, product code DWL), submitted by Surgical Appliance Industries, Inc. (Cincinnati, US). The FDA issued a Cleared decision on April 27, 2012, 15 days after receiving the submission on April 12, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5780.

Submission Details

510(k) Number	K121106 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 2012
Decision Date	April 27, 2012
Days to Decision	15 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