Cleared Traditional

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

K855249 is an FDA 510(k) clearance for MIDIFICATION SYS*STIM 207 (MODEL-ME207), manufactured by Mettler Electronics Corp.. The device is a Class 2 Physical Medicine device with 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.

FDA 510(k) Submission Details - K855249

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 116d · This submission: 92d
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 547
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K855249.
ES 180-DCM MUSCLE STIMULATOR
K860619 · Promatek · May 1986
VACO SUCTION ELECTRODE UNIT
K860758 · Zimmer Elektromedizin GmbH · May 1986
HV-4
K853154 · Robert Bosch Corp. · Mar 1986
SYS*STIM 206 (MODEL-ME 206)
K860107 · Mettler Electronics Corp. · Mar 1986
MS-189 MUSCLE STIMULATOR
K854801 · Electro Med Supply, Inc. · Mar 1986
NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM.
K854720 · Nemectron Medical, Inc. · Mar 1986
K855249 · MIDIFICATION SYS*STIM 207 (MODEL-ME207)
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