Cleared Traditional

K901849 - LUMISCOPE EMS 8000

K901849 is an FDA 510(k) clearance for LUMISCOPE EMS 8000, manufactured by Lumiscope Co., Inc.. The device is a Class 2 Physical Medicine device with 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.

FDA 510(k) Submission Details - K901849

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 116d · This submission: 122d
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 538
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K901849.
CHALLENGE 8000 POWERED MUSCLE STIMULATOR
K902512 · Maximum Performance Technologies, Mpts, Inc. · Aug 1990
CHALLENGE 6010 POWERED MUSCLE STIMULATOR
K902513 · Maximum Performance Technologies, Mpts, Inc. · Aug 1990
CHALLENGE 5010 POWERED MUSCLE STIMULATOR
K902514 · Maximum Performance Technologies, Mpts, Inc. · Aug 1990
LINDQUIST MODEL SS POWERED MUSCLE STIMULATOR
K892960 · R.J. Lindquist Co. · Aug 1990
LINDQUIST MODEL 370
K893980 · R.J. Lindquist Co. · Aug 1990
CHALLENGE 5000 POWERED MUSCLE STIMULATOR
K901768 · Maximum Performance Technologies, Mpts, Inc. · Jul 1990
K901849 · LUMISCOPE EMS 8000
Download PDF Lumiscope Co., Inc.