Cleared Traditional

K982668 - PHORESOR II,MODEL PM900

K982668 is an FDA 510(k) clearance for PHORESOR II, manufactured by Iomed, Inc.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K982668 · Iomed, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
214d
Days
Class 2
Risk

K982668 is an FDA 510(k) clearance for the PHORESOR II,MODEL PM900. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Iomed, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 2, 1999 after a review of 214 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.

FDA 510(k) Submission Details - K982668

510(k) Number K982668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1998
Decision Date March 02, 1999
Days to Decision 214 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
98d slower than avg
Panel avg: 116d · This submission: 214d
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 67
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K982668.
IO-DRIVE
K993081 · Selectivemed Components, Inc. · Mar 2000
IONTOPATCH
K992708 · Birch Point Medical, Inc. · Feb 2000
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
MD-1A GALVANIC UNIT
K964208 · R. A. Fischer Co. Corp. · Apr 1997
K982668 · PHORESOR II,MODEL PM900
Download PDF FDA Summary Iomed, Inc.