Cleared Abbreviated

K113017 - SYS*STIM 240

K113017 is an FDA 510(k) clearance for SYS*STIM 240, manufactured by Mettler Electronics Corp.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Abbreviated 510(k) pathway after a 259-day FDA review.

K113017 · Mettler Electronics Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
259d
Days
Class 2
Risk

K113017 is an FDA 510(k) clearance for the SYS*STIM 240. 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 June 26, 2012 after a review of 259 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Mettler Electronics Corp. devices

FDA 510(k) Submission Details - K113017

510(k) Number K113017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2011
Decision Date June 26, 2012
Days to Decision 259 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 115d · This submission: 259d
Pathway characteristics
Standards-based clearance path.

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 257
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K113017.
MUSCLE STIMULATION SYSTEM
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POWERED MUSCLE STIMULATOR
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K111279 · Zynex Medical, Inc. · Sep 2011