Cleared Traditional

K993081 - IO-DRIVE

K993081 is an FDA 510(k) clearance for IO-DRIVE, manufactured by Selectivemed Components, Inc.. The device is a Class 2 Physical Medicine device with 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

FDA 510(k) Submission Details - K993081

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
Combination Product No
PCCP Authorized No
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.

EGJ Device Classification - Class 2, Special Controls

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 46
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K993081.
MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE
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EMPI ACTION PATCH IONTOPHORESIS SYSTEM
K030395 · Empi · Apr 2003
IONTOPATCH
K992708 · Birch Point Medical, Inc. · Feb 2000
DUPEL IONTOPHORESIS SYSTEM
K991991 · Empi · Sep 1999
PHORESOR II,MODEL PM900
K982668 · Iomed, Inc. · Mar 1999