Cleared Traditional

K994057 - SLENDAIR 4000 COMPRESSION SYSTEM

K994057 is an FDA 510(k) clearance for SLENDAIR 4000 COMPRESSION SYSTEM, manufactured by Medical Compression Systems (Dbn) , Ltd.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K994057 · Medical Compression Systems (Dbn) , Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
94d
Days
Class 2
Risk

K994057 is an FDA 510(k) clearance for the SLENDAIR 4000 COMPRESSION SYSTEM. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Medical Compression Systems (Dbn) , Ltd. (Ra'Ananna 43373, IL). The FDA issued a Cleared decision on March 3, 2000 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - the FDA physical medicine device 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

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

FDA 510(k) Submission Details - K994057

510(k) Number K994057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1999
Decision Date March 03, 2000
Days to Decision 94 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 115d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRP Device Classification - Class 2, Special Controls

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IRP Massager, Powered Inflatable Tube

All 101
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