Cleared Traditional

K932399 - THERAPEUTIC STIM 200 (TS-200)/200P (TS-...

K932399 is an FDA 510(k) clearance for THERAPEUTIC STIM 200 (TS-200)/200P (TS-..., manufactured by Myo/Kinetic Systems, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K932399 · Myo/Kinetic Systems, Inc. · Physical Medicine device
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Aug 1993
Decision
85d
Days
Class 2
Risk

K932399 is an FDA 510(k) clearance for the THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P). Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Myo/Kinetic Systems, Inc. (Menomonee Falls, US). The FDA issued a Cleared decision on August 11, 1993 after a review of 85 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 Myo/Kinetic Systems, Inc. devices

FDA 510(k) Submission Details - K932399

510(k) Number K932399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1993
Decision Date August 11, 1993
Days to Decision 85 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
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 158
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K932399.
FORTE ES-400
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K923914 · Medical Devices, Inc. · Nov 1992
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K920833 · Rich-Mar Corp. · May 1992
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K920436 · Medtronic Vascular · May 1992