Cleared Special

K023573 - WIZAIR COMPRESSION SYSTEM

K023573 is an FDA 510(k) clearance for WIZAIR COMPRESSION SYSTEM, manufactured by Medical Compression Systems (Dbn) , Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Special 510(k) pathway after a 28-day FDA review.

K023573 · Medical Compression Systems (Dbn) , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
28d
Days
Class 2
Risk

K023573 is an FDA 510(k) clearance for the WIZAIR COMPRESSION SYSTEM. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Medical Compression Systems (Dbn) , Ltd. (Ra'Ananna 43373, IL). The FDA issued a Cleared decision on November 21, 2002 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medical Compression Systems (Dbn) , Ltd. devices

FDA 510(k) Submission Details - K023573

510(k) Number K023573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2002
Decision Date November 21, 2002
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 126
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K023573.
REPROCESSED COMPRESSION SLEEVES
K053316 · Alliance Medical Corp. · Feb 2006
REPROCESSED COMPRESSION SLEEVES
K024087 · Alliance Medical Corp. · Mar 2003
REPROCESSED COMPRESSION SLEEVES
K024074 · Alliance Medical Corp. · Mar 2003
STERILMED REPROCESSED COMPRESSION SLEEVES
K012597 · Sterilmed, Inc. · Feb 2002
COMPRESSIBLE LIMB SLEEVE
K011192 · Alliance Medical Corp. · Nov 2001
VENODYNE DVT ADVANTAGE PLUS
K011318 · Microtek Medical, Inc. · Oct 2001