Cleared Traditional

K855249 - MIDIFICATION SYS*STIM 207 (MODEL-ME207)

K855249 is the FDA 510(k) clearance for MIDIFICATION SYS*STIM 207 (MODEL-ME207) by Mettler Electronics Corp.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K855249 · Mettler Electronics Corp. · Physical Medicine device
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Mar 1986
Decision
92d
Days
Class 2
Risk

K855249 is an FDA 510(k) clearance for the MIDIFICATION SYS*STIM 207 (MODEL-ME207). 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 March 28, 1986 after a review of 92 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 K855249 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 26, 1985
Decision Date March 28, 1986
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
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 K855249.
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MYOCARE PLUS DUAL CHANNEL STIMULATOR
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