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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 116d · 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 370
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K993821.
CONTROL SOLUTIONS INC, MODEL CS3101
K993420 · Control Solutions, Inc. · Jul 2000
HMS NEUROMUSCULAR STIMULATOR
K994062 · Home Medical Services, Inc. · Apr 2000
MS-ONE, MODEL MS-1
K994065 · Home Wellness West · Apr 2000
IF8000
K991241 · Dan Med, Inc. · Nov 1999
TRIO 300
K990787 · Ito Co., Ltd. · Oct 1999
RS-4V MUSCLE STIMULATOR
K990697 · Rs Medical · Jun 1999
K993821 · VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT
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