Cleared Traditional

K964028 - SYS STIM 226

K964028 is an FDA 510(k) clearance for SYS STIM 226, 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 119-day FDA review.

K964028 · Mettler Electronics Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K964028

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.

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 269
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K964028.
ORTHO DX NEUROMUSCULAR STIMULATOR
K971542 · Rehabilicare, Inc. · Aug 1997
EGS4000
K955666 · S&P Electrical Industries, Inc. · Apr 1997
NEURO-TRAIN II (2)
K970155 · Sterne Equipment Co., Ltd. · Mar 1997
AXIOM INF
K964423 · Axiom Manufacturing · Jan 1997
XH-1 NEUROMUSCULAR STIMULATOR
K950550 · California Medical Research Institute · Dec 1996
MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR
K962462 · Smith and Nephew Donjoy, Inc. · Sep 1996