Cleared Traditional

K132832 - ACTIVAPATCH ET IONTOPHORESIS PATCH

K132832 is an FDA 510(k) clearance for ACTIVAPATCH ET IONTOPHORESIS PATCH, manufactured by Activatek, Inc.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K132832 · Activatek, Inc. · Physical Medicine device
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Feb 2014
Decision
156d
Days
Class 2
Risk

K132832 is an FDA 510(k) clearance for the ACTIVAPATCH ET IONTOPHORESIS PATCH. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Activatek, Inc. (West Valley City, US). The FDA issued a Cleared decision on February 13, 2014 after a review of 156 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 Activatek, Inc. devices

FDA 510(k) Submission Details - K132832

510(k) Number K132832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2013
Decision Date February 13, 2014
Days to Decision 156 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 115d · This submission: 156d
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 32
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K132832.
Saalio
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Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
K170835 · Hightech Development · Jun 2018
TULA Iontophoresis System with Earset
K150453 · Acclarent, Inc. · May 2015
TULA IONTOPHORESIS SYSTEM
K110636 · Acclarent, Inc. · Jun 2011
IONTOPHORESIS SYSTEM
K073276 · Acclarent, Inc. · Mar 2008
HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
K072946 · Empi · Nov 2007