Cleared Traditional

THERAPEUTIC STIMULATOR 2100 (TS-2100) (K914904) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K914904 · Myo/Kinetic Systems, Inc. · Physical Medicine device
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Apr 1992
Decision
179d
Days
Class 2
Risk

K914904 is an FDA 510(k) clearance for the THERAPEUTIC STIMULATOR 2100 (TS-2100). 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 April 28, 1992 after a review of 179 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.

View all Myo/Kinetic Systems, Inc. devices

Submission Details

510(k) Number K914904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1991
Decision Date April 28, 1992
Days to Decision 179 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
64d slower than avg
Panel avg: 115d · This submission: 179d
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 546
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