Cleared Special

K072946 - HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM

K072946 is an FDA 510(k) clearance for HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM, manufactured by Empi. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Special 510(k) pathway after a 30-day FDA review.

K072946 · Empi · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
30d
Days
Class 2
Risk

K072946 is an FDA 510(k) clearance for the HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Empi (St. Paul, US). The FDA issued a Cleared decision on November 16, 2007 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5525 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K072946

510(k) Number K072946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2007
Decision Date November 16, 2007
Days to Decision 30 days
Submission Type Special
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
86d faster than avg
Panel avg: 116d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 69
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K072946.
ACTIVAPATCH
K091326 · Activatek, Inc. · May 2009
COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D
K080580 · Axelgaard Mfg. Co., Ltd. · Jun 2008
IONTOPHORESIS SYSTEM
K073276 · Acclarent, Inc. · Mar 2008
DUPEL TRANSPORT IONTOPHORESIS SYSTEM
K070427 · Empi · May 2007
MESODERM
K061849 · Aa Advanced Technology, Inc. · Apr 2007
ERCHONIA IOTO_240
K062792 · Erchonia Medical, Inc. · Mar 2007
K072946 · HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
Download PDF FDA Summary Empi