Cleared Traditional

K850013 - SYS STIM 206(MODEL-ME 206) MUSCLE STIMU...

K850013 is the FDA 510(k) clearance for SYS STIM 206(MODEL-ME 206) MUSCLE STIMU... by Mettler Electronics Corp.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K850013 · Mettler Electronics Corp. · Physical Medicine device
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Apr 1985
Decision
96d
Days
Class 2
Risk

K850013 is an FDA 510(k) clearance for the SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on April 8, 1985 after a review of 96 days - within the typical 510(k) review window.

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 Mettler Electronics Corp. devices

Submission Details

510(k) Number K850013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1985
Decision Date April 08, 1985
Days to Decision 96 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
19d faster than avg
Panel avg: 115d · This submission: 96d
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 135
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K850013.
EMPI MODEL 730 NMS
K854775 · Empi · Feb 1986
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K851046 · 3M Company · Jul 1985
MEDIUM FREQU. ELEC. MUSCLE STIMULATOR
K850698 · Chattanooga Group, Inc. · May 1985
EXCEL TECH MST-7 ISOELECTRONIC THERAPY DEVICE
K844617 · Excel Tech. , Ltd. · Mar 1985
THE PROBE 100
K844466 · Rich-Mar Corp. · Feb 1985
NEUROMEDICS ULTRASTIM 650-01
K841647 · Intermedics, Inc. · Jul 1984