Cleared Traditional

K914774 - MULTIPULSE SEQUENTIAL COMPRESSION UNIT

K914774 is an FDA 510(k) clearance for MULTIPULSE SEQUENTIAL COMPRESSION UNIT, manufactured by Talley Group, Ltd.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K914774 · Talley Group, Ltd. · Physical Medicine device
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Feb 1992
Decision
111d
Days
Class 2
Risk

K914774 is an FDA 510(k) clearance for the MULTIPULSE SEQUENTIAL COMPRESSION UNIT. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Talley Group, Ltd. (Lansing, US). The FDA issued a Cleared decision on February 11, 1992 after a review of 111 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.

FDA 510(k) Submission Details - K914774

510(k) Number K914774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1991
Decision Date February 11, 1992
Days to Decision 111 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 116d · This submission: 111d
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 157
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K914774.
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CRYOPRESS
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TALLEY TM300 SEQUENTIAL MULTICOM COMPRESSION SYST
K915092 · Progressive Medical Technology, Inc. · Feb 1992
TALLEY TM500 SEQUENTIAL MULTICOM COMPRESSION SYST.
K915637 · Progressive Medical Technology, Inc. · Feb 1992
TALLEY TM200 INTERMTTENT COMPRESSION UNIT
K915638 · Progressive Medical Technology, Inc. · Feb 1992
K914774 · MULTIPULSE SEQUENTIAL COMPRESSION UNIT
Download PDF Talley Group, Ltd.