Cleared Traditional

K964028 - SYS STIM 226

K964028 is the FDA 510(k) clearance for SYS STIM 226 by Mettler Electronics Corp.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K964028 · Mettler Electronics Corp. · Physical Medicine device
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Feb 1997
Decision
119d
Days
Class 2
Risk

K964028 is an FDA 510(k) clearance for the SYS STIM 226. 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 February 3, 1997 after a review of 119 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 K964028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1996
Decision Date February 03, 1997
Days to Decision 119 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 115d · This submission: 119d
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 143
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K964028.
SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994
K984142 · Mettler Electronics Corp. · Feb 1999
FORTE, MODELS CPS 400 STIM, CPS 200 STIM
K982828 · Chattanooga Group, Inc. · Nov 1998
MODEL PS-1 PENA MUSCLE STIMULATOR
K980448 · Radionics, Inc. · Apr 1998
ULTRA III
K960096 · Excel Tech. , Ltd. · Mar 1996
ULTRA IV
K960489 · Excel Tech. , Ltd. · Mar 1996
FORTE ES-400
K953615 · Chattanooga Group, Inc. · Oct 1995