Cleared Traditional

K984113 - MS400

K984113 is an FDA 510(k) clearance for MS400, 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 72-day FDA review.

K984113 · Lsi Intl., Inc. · Physical Medicine device
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Jan 1999
Decision
72d
Days
Class 2
Risk

K984113 is an FDA 510(k) clearance for the MS400. 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 January 28, 1999 after a review of 72 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lsi Intl., Inc. devices

FDA 510(k) Submission Details - K984113

510(k) Number K984113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1998
Decision Date January 28, 1999
Days to Decision 72 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
43d faster than avg
Panel avg: 115d · This submission: 72d
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 197
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K984113.
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT
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