Cleared Traditional

K914142 - HEMO-PULSE 2000

K914142 is an FDA 510(k) clearance for HEMO-PULSE 2000, manufactured by Chrono Dynamics, Ltd.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K914142 · Chrono Dynamics, Ltd. · Physical Medicine device
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Jan 1992
Decision
109d
Days
Class 2
Risk

K914142 is an FDA 510(k) clearance for the HEMO-PULSE 2000. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Chrono Dynamics, Ltd. (Dayton, US). The FDA issued a Cleared decision on January 3, 1992 after a review of 109 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 Chrono Dynamics, Ltd. devices

FDA 510(k) Submission Details - K914142

510(k) Number K914142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1991
Decision Date January 03, 1992
Days to Decision 109 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 115d · This submission: 109d
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 132
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K914142.
ATLANT'S
K974395 · Grad-Line Corp. · Oct 1998
INTERMITTENT COMPRESSOR SYSTEM
K964957 · Eischoco, Inc. · Feb 1997
BIO BOOST
K961426 · Bio Compression Systems, Inc. · Oct 1996
FLOWTRON AC200/2
K874688 · Huntleigh Technology, Inc. · Sep 1988
EBI HAND MASSAGING PUMP (HMP)
K860632 · Electro-Biology, Inc. · Apr 1986
EBI FOOT MASSAGING PUMP
K852264 · Electro-Biology, Inc. · Jul 1985