Cleared Traditional

K800486 - STIM-EX 201

K800486 is the FDA 510(k) clearance for STIM-EX 201 by Th Charters, Inc.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K800486 · Th Charters, Inc. · Physical Medicine device
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Mar 1980
Decision
15d
Days
Class 2
Risk

K800486 is an FDA 510(k) clearance for the STIM-EX 201. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Th Charters, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1980 after a review of 15 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 Th Charters, Inc. devices

Submission Details

510(k) Number K800486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1980
Decision Date March 19, 1980
Days to Decision 15 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
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.