Cleared Special

PBS MODEL 701A COMPRESSION THERAPY DEVICE (K060220) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K060220 · Mego Afek · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
10d
Days
Class 2
Risk

K060220 is an FDA 510(k) clearance for the PBS MODEL 701A COMPRESSION THERAPY DEVICE. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Mego Afek (Kfar Saba, IL). The FDA issued a Cleared decision on February 9, 2006 after a review of 10 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 Mego Afek devices

Submission Details

510(k) Number K060220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2006
Decision Date February 09, 2006
Days to Decision 10 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
115d faster than avg
Panel avg: 125d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 92
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K060220.
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