Cleared Traditional

K933653 - MS 2500

K933653 is an FDA 510(k) clearance for MS 2500, manufactured by Lsi Intl., Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K933653 · Lsi Intl., Inc. · Physical Medicine device
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Mar 1994
Decision
238d
Days
Class 2
Risk

K933653 is an FDA 510(k) clearance for the MS 2500. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Lsi Intl., Inc. (Overland Park, US). The FDA issued a Cleared decision on March 23, 1994 after a review of 238 days - an extended review cycle.

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 - K933653

510(k) Number K933653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1993
Decision Date March 23, 1994
Days to Decision 238 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 116d · This submission: 238d
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 422
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K933653.
THE SIGNATURE SERIES, MAGNUM 100
K934919 · Progressive Electrical Therapeutics · Apr 1994
NEUROMUSCULAR ELECTRICAL STIMULATOR
K940349 · Progressive Concepts, Inc. · Apr 1994
EMS
K931401 · Saratoga Intl., Inc. · Mar 1994
POWERED MUSCLE STIMULATOR
K932898 · Nemectron GmbH · Mar 1994
HVGS 9000
K926084 · Shevlin Medical, Inc. · Mar 1994
THE SIGNATURE SERIES, IC IV
K933195 · Progressive Electrical Therapeutics · Feb 1994
K933653 · MS 2500
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