Cleared Traditional

K022950 - MINIPHYSIONIZER 2.0 AND ELECTRODES

K022950 is an FDA 510(k) clearance for MINIPHYSIONIZER 2.0 AND ELECTRODES, manufactured by Physion, Inc.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K022950 · Physion, Inc. · Physical Medicine device
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Apr 2003
Decision
225d
Days
Class 2
Risk

K022950 is an FDA 510(k) clearance for the MINIPHYSIONIZER 2.0 AND ELECTRODES. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Physion, Inc. (Short Hills, US). The FDA issued a Cleared decision on April 18, 2003 after a review of 225 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 Physion, Inc. devices

FDA 510(k) Submission Details - K022950

510(k) Number K022950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2002
Decision Date April 18, 2003
Days to Decision 225 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 115d · This submission: 225d
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 59
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K022950.
DYNATRON IBOX IONTOPHORESIS DEVICE
K043047 · Dynatronics Corp. · Jan 2005
TRANSDERM IONTO SYSTEM, MK 2
K042590 · Mattioli Engineering Corp. · Oct 2004
MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001
K041101 · Medical Adhesiveonline, LLC · Jul 2004
EMPI ACTION PATCH IONTOPHORESIS SYSTEM
K030395 · Empi · Apr 2003
IO-DRIVE
K993081 · Selectivemed Components, Inc. · Mar 2000
IONTOPATCH
K992708 · Birch Point Medical, Inc. · Feb 2000