Cleared Traditional

K901849 - LUMISCOPE EMS 8000

K901849 is the FDA 510(k) clearance for LUMISCOPE EMS 8000 by Lumiscope Co., Inc.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K901849 · Lumiscope Co., Inc. · Physical Medicine device
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Aug 1990
Decision
122d
Days
Class 2
Risk

K901849 is an FDA 510(k) clearance for the LUMISCOPE EMS 8000. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Lumiscope Co., Inc. (Edison, US). The FDA issued a Cleared decision on August 24, 1990 after a review of 122 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 Lumiscope Co., Inc. devices

Submission Details

510(k) Number K901849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1990
Decision Date August 24, 1990
Days to Decision 122 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
7d slower than avg
Panel avg: 115d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 87
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K901849.
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · Smith & Nephew, Inc. · May 1994
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
K920436 · Medtronic Vascular · May 1992
REVISED HIGH VOLTAGE STIMULATOR INTELECT 150
K902599 · Chattanooga Group, Inc. · Oct 1990
INTELECT 775MP POWERED MUSCLE STIMULATOR
K900413 · Chattanooga Group, Inc. · Mar 1990
INTELECT MODEL 120
K880235 · Chattanooga Group, Inc. · Apr 1988
INTELECT VMS 2, OR INTELECT VMS II
K880234 · Chattanooga Group, Inc. · Feb 1988