Cleared Traditional

K993081 - IO-DRIVE

K993081 is the FDA 510(k) clearance for IO-DRIVE by Selectivemed Components, Inc.. It is a Class 2 Physical Medicine device (product code EGJ) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K993081 · Selectivemed Components, Inc. · Physical Medicine device
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Mar 2000
Decision
170d
Days
Class 2
Risk

K993081 is an FDA 510(k) clearance for the IO-DRIVE. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Selectivemed Components, Inc. (Mount Vernon, US). The FDA issued a Cleared decision on March 3, 2000 after a review of 170 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5525 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Selectivemed Components, Inc. devices

Submission Details

510(k) Number K993081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1999
Decision Date March 03, 2000
Days to Decision 170 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 115d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EGJ Device, Iontophoresis, Other Uses
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5525
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 - EGJ Device, Iontophoresis, Other Uses

All 24
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K993081.
HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
K072946 · Empi · Nov 2007
DUPEL TRANSPORT IONTOPHORESIS SYSTEM
K070427 · Empi · May 2007
EMPI ACTION PATCH IONTOPHORESIS SYSTEM
K030395 · Empi · Apr 2003
DUPEL IONTOPHORESIS SYSTEM
K991991 · Empi · Sep 1999
DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE
K983484 · Empi · Dec 1998
DUPEL II BUFFERED IONTOPHORESIS ELECTRODES
K970491 · Empi · May 1997