Cleared Traditional

K860619 - ES 180-DCM MUSCLE STIMULATOR

K860619 is an FDA 510(k) clearance for ES 180-DCM MUSCLE STIMULATOR, manufactured by Promatek. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K860619 · Promatek · Physical Medicine device
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May 1986
Decision
100d
Days
Class 2
Risk

K860619 is an FDA 510(k) clearance for the ES 180-DCM MUSCLE STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Promatek (Canada H4p 2c9, CA). The FDA issued a Cleared decision on May 30, 1986 after a review of 100 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 Promatek devices

FDA 510(k) Submission Details - K860619

510(k) Number K860619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1986
Decision Date May 30, 1986
Days to Decision 100 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
15d faster than avg
Panel avg: 115d · This submission: 100d
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 K860619.
EMPI MODEL 712, LOGIX(TM), NMS
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INTERSTIM 100 SYSTEM
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RICH-MAR IF 200
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HV-4
K853154 · Robert Bosch Corp. · Mar 1986
MIDIFICATION SYS*STIM 207 (MODEL-ME207)
K855249 · Mettler Electronics Corp. · Mar 1986
SYS*STIM 206 (MODEL-ME 206)
K860107 · Mettler Electronics Corp. · Mar 1986