Cleared Traditional

K020211 - BODY FORCE, MODEL BT 6000

K020211 is an FDA 510(k) clearance for BODY FORCE, manufactured by Composites Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K020211 · Composites Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Jun 2002
Decision
157d
Days
Class 2
Risk

K020211 is an FDA 510(k) clearance for the BODY FORCE, MODEL BT 6000. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Composites Solutions, Inc. (West Columbia, US). The FDA issued a Cleared decision on June 28, 2002 after a review of 157 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Composites Solutions, Inc. devices

FDA 510(k) Submission Details - K020211

510(k) Number K020211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2002
Decision Date June 28, 2002
Days to Decision 157 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 125d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 235
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K020211.
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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