Cleared Special

K993821 - VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT

K993821 is an FDA 510(k) clearance for VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT, 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 27-day FDA review.

K993821 · Metron Medical Australia, Pty, Ltd. · Physical Medicine device
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Dec 1999
Decision
27d
Days
Class 2
Risk

K993821 is an FDA 510(k) clearance for the VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT. 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 December 9, 1999 after a review of 27 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.

View all Metron Medical Australia, Pty, Ltd. devices

FDA 510(k) Submission Details - K993821

510(k) Number K993821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1999
Decision Date December 09, 1999
Days to Decision 27 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
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 174
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K993821.
MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T
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SMITH & NEPHEW RESTIM
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RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
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SYS STIM 294, MODEL ME 294
K984114 · Mettler Electronics Corp. · Feb 1999
SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994
K984142 · Mettler Electronics Corp. · Feb 1999
FORTE, MODELS CPS 400 STIM, CPS 200 STIM
K982828 · Chattanooga Group, Inc. · Nov 1998