Cleared Traditional

K925800 - RH-806, MODEL TRANSQ

K925800 is an FDA 510(k) clearance for RH-806, 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 605-day FDA review.

K925800 · Iomed, Inc. · Physical Medicine device
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Jul 1994
Decision
605d
Days
Class 2
Risk

K925800 is an FDA 510(k) clearance for the RH-806, MODEL TRANSQ. 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 14, 1994 after a review of 605 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Iomed, Inc. devices

FDA 510(k) Submission Details - K925800

510(k) Number K925800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1992
Decision Date July 14, 1994
Days to Decision 605 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
490d slower than avg
Panel avg: 115d · This submission: 605d
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 K925800.
PHORESOR II AUTO, MODEL PM800 MODIFICATION
K934335 · Iomed, Inc. · Jul 1994
MICROPHOR
K913601 · Life-Tech Intl., Inc. · Jul 1994
DUPEL IONTOPHORESIS DEVICE
K915444 · Empi · Jul 1994
RH-801, MODEL TRANSQ
K925806 · Iomed, Inc. · Jul 1994
TRANSQ 2
K914264 · Iomed, Inc. · Dec 1991
IONTOPHORESIS DEVICE, MODIFICATION
K914621 · Iomed, Inc. · Dec 1991