Cleared Traditional

K061522 - TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM

K061522 is an FDA 510(k) clearance for TRIVARION BUFFERED IONTOPHORESIS ELECTR..., 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 60-day FDA review.

K061522 · Activatek, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
60d
Days
Class 2
Risk

K061522 is an FDA 510(k) clearance for the TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Activatek, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 1, 2006 after a review of 60 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K061522

510(k) Number K061522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2006
Decision Date August 01, 2006
Days to Decision 60 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
56d faster than avg
Panel avg: 116d · This submission: 60d
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 65
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K061522.
MESODERM
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