Cleared Special

K132137 - MULTISTIM

K132137 is an FDA 510(k) clearance for MULTISTIM, manufactured by Metron Medical Australia, Pty, Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Special 510(k) pathway after a 63-day FDA review.

K132137 · Metron Medical Australia, Pty, Ltd. · Physical Medicine device
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Sep 2013
Decision
63d
Days
Class 2
Risk

K132137 is an FDA 510(k) clearance for the MULTISTIM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Metron Medical Australia, Pty, Ltd. (Carrum Downs, AU). The FDA issued a Cleared decision on September 12, 2013 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K132137

510(k) Number K132137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2013
Decision Date September 12, 2013
Days to Decision 63 days
Submission Type Special
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
53d faster than avg
Panel avg: 116d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

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 370
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