Cleared Traditional

K844580 - MEDCOLATOR MODEL HVX

K844580 is an FDA 510(k) clearance for MEDCOLATOR MODEL HVX, manufactured by Medco Products, Co., Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K844580 · Medco Products, Co., Inc. · Physical Medicine device
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Feb 1985
Decision
94d
Days
Class 2
Risk

K844580 is an FDA 510(k) clearance for the MEDCOLATOR MODEL HVX. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Medco Products, Co., Inc. (Tinton Falls, US). The FDA issued a Cleared decision on February 25, 1985 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 890.5850 - 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 Medco Products, Co., Inc. devices

FDA 510(k) Submission Details - K844580

510(k) Number K844580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1984
Decision Date February 25, 1985
Days to Decision 94 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
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.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 - IPF Stimulator, Muscle, Powered

All 273
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K844580.
MEDIUM FREQU. ELEC. MUSCLE STIMULATOR
K850698 · Chattanooga Group, Inc. · May 1985
SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR
K850013 · Mettler Electronics Corp. · Apr 1985
EXCEL TECH MST-7 ISOELECTRONIC THERAPY DEVICE
K844617 · Excel Tech. , Ltd. · Mar 1985
THE PROBE 100
K844466 · Rich-Mar Corp. · Feb 1985
INTERFERENZ 4
K842803 · Robert Bosch Corp. · Aug 1984
DIADYN 4
K842804 · Robert Bosch Corp. · Aug 1984