Cleared Traditional

K894549 - DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE

K894549 is an FDA 510(k) clearance for DYNAPHOR(TM) 101, manufactured by Henley Intl.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K894549 · Henley Intl. · Physical Medicine device
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Feb 1990
Decision
204d
Days
Class 2
Risk

K894549 is an FDA 510(k) clearance for the DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on February 9, 1990 after a review of 204 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 Henley Intl. devices

FDA 510(k) Submission Details - K894549

510(k) Number K894549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received July 20, 1989
Decision Date February 09, 1990
Days to Decision 204 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 115d · This submission: 204d
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 54
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K894549.
IONTOPHORESIS DEVICE
K903093 · Empi · Oct 1990
IONTOPHORESIS DEVICE - ELECTRODE RH 800
K896444 · Iomed, Inc. · May 1990
TBD IONTOPHORESIS ELECTRODE
K896703 · Empi · Feb 1990
XOMED IONESTHETIZER(TM)
K884834 · Xomed, Inc. · Feb 1989
MEDITRODE KIT
K882554 · Life-Tech Intl., Inc. · Dec 1988
MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI.
K871869 · Life-Tech Intl., Inc. · Aug 1987