Cleared Abbreviated

K091540 - MTD 4000

K091540 is an FDA 510(k) clearance for MTD 4000, manufactured by Mettler Electronics Corp.. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Abbreviated 510(k) pathway after a 135-day FDA review.

K091540 · Mettler Electronics Corp. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
135d
Days
Class 2
Risk

K091540 is an FDA 510(k) clearance for the MTD 4000. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on October 8, 2009 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5900 - 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.

FDA 510(k) Submission Details - K091540

510(k) Number K091540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2009
Decision Date October 08, 2009
Days to Decision 135 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
19d slower than avg
Panel avg: 116d · This submission: 135d
Pathway characteristics
Standards-based clearance path.

ITH Device Classification - Class 2, Special Controls

Product Code ITH Equipment, Traction, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5900
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 - ITH Equipment, Traction, Powered

All 70
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K091540.
EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800
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INTEGRITY SPINAL CARE SYSTEM
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DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
K101889 · Pivotal Health Solutions · Aug 2010
TM-400
K081247 · Ito Co., Ltd. · Aug 2008
GRAVILAX TRACTION SYSTEM
K072064 · Therapeutic Clinical Technologies, Inc. · Apr 2008
MODEL D DISC FORCE
K073132 · North American Medical Corp (Nam) · Apr 2008
K091540 · MTD 4000
Download PDF FDA Summary Mettler Electronics C…