Cleared Special

K003260 - VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460

K003260 is an FDA 510(k) clearance for VECTORSURGE 4 INTERFERENTIAL THERAPY UN..., 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 127-day FDA review.

K003260 · Metron Medical Australia, Pty, Ltd. · Physical Medicine device
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Feb 2001
Decision
127d
Days
Class 2
Risk

K003260 is an FDA 510(k) clearance for the VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460. 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 February 22, 2001 after a review of 127 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. 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. Standard predicate reliance. 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 - K003260

510(k) Number K003260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2000
Decision Date February 22, 2001
Days to Decision 127 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
11d slower than avg
Panel avg: 116d · This submission: 127d
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
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K003260.
SMITH & NEPHEW RESTIM
K003596 · Smith & Nephew, Inc. · Jun 2001
VECTORSURGE 5, MODEL VS-500
K002058 · Metron Medical Australia, Pty, Ltd. · May 2001
TRANSAMERICA DIGITAL EMS
K010665 · Transamerica Medical Systems · Apr 2001
RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
K000808 · Rich-Mar Corp. · Aug 2000
RS-4M+MUSCLE STIMULATOR
K000114 · Rs Medical · Aug 2000
CONTROL SOLUTIONS INC, MODEL CS3101
K993420 · Control Solutions, Inc. · Jul 2000
K003260 · VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
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