Cleared Traditional

K991921 - INTERMITTENT COMPRESSION BOOT FOR OTC

K991921 is an FDA 510(k) clearance for INTERMITTENT COMPRESSION BOOT FOR OTC, manufactured by Eischoco, Inc.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K991921 · Eischoco, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
67d
Days
Class 2
Risk

K991921 is an FDA 510(k) clearance for the INTERMITTENT COMPRESSION BOOT FOR OTC. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Eischoco, Inc. (Gresham, US). The FDA issued a Cleared decision on August 13, 1999 after a review of 67 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Eischoco, Inc. devices

FDA 510(k) Submission Details - K991921

510(k) Number K991921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1999
Decision Date August 13, 1999
Days to Decision 67 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
48d faster than avg
Panel avg: 115d · This submission: 67d
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 111
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K991921.
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INTERMITTENT COMPRESSOR SYSTEM
K964957 · Eischoco, Inc. · Feb 1997
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K874688 · Huntleigh Technology, Inc. · Sep 1988