Cleared Traditional

K934335 - PHORESOR II AUTO, MODEL PM800 MODIFICATION

K934335 is an FDA 510(k) clearance for PHORESOR II AUTO, 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 322-day FDA review.

K934335 · Iomed, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
322d
Days
Class 2
Risk

K934335 is an FDA 510(k) clearance for the PHORESOR II AUTO, MODEL PM800 MODIFICATION. 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 July 26, 1994 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Iomed, Inc. devices

FDA 510(k) Submission Details - K934335

510(k) Number K934335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1993
Decision Date July 26, 1994
Days to Decision 322 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
207d slower than avg
Panel avg: 115d · This submission: 322d
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 42
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K934335.
DYNAPHOR(TM) TWO
K935868 · Maxxim Medical · Mar 1995
RH-806/GS MODEL TRANSQ(R)2
K932620 · Iomed, Inc. · Jul 1994
RH-801/GS MODEL TRANSQ(R)1
K932621 · Iomed, Inc. · Jul 1994
MICROPHOR
K913601 · Life-Tech Intl., Inc. · Jul 1994
DUPEL IONTOPHORESIS DEVICE
K915444 · Empi · Jul 1994
RH-806, MODEL TRANSQ
K925800 · Iomed, Inc. · Jul 1994