Cleared Traditional

K964957 - INTERMITTENT COMPRESSOR SYSTEM

K964957 is an FDA 510(k) clearance for INTERMITTENT COMPRESSOR SYSTEM, 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 75-day FDA review.

K964957 · Eischoco, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
75d
Days
Class 2
Risk

K964957 is an FDA 510(k) clearance for the INTERMITTENT COMPRESSOR SYSTEM. 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 February 24, 1997 after a review of 75 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 - K964957

510(k) Number K964957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1996
Decision Date February 24, 1997
Days to Decision 75 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 115d · This submission: 75d
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 110
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