Cleared Traditional

K123354 - REVITIVE IX

K123354 is an FDA 510(k) clearance for REVITIVE IX, manufactured by Actegy , Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K123354 · Actegy , Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
240d
Days
Class 2
Risk

K123354 is an FDA 510(k) clearance for the REVITIVE IX. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Actegy , Ltd. (Washington, US). The FDA issued a Cleared decision on June 28, 2013 after a review of 240 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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 Actegy , Ltd. devices

FDA 510(k) Submission Details - K123354

510(k) Number K123354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2012
Decision Date June 28, 2013
Days to Decision 240 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
124d slower than avg
Panel avg: 116d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 - IPF Stimulator, Muscle, Powered

All 299
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K123354.
AMPCARE ESP THERAPY SYSTEM
K131222 · Ampcare, LLC · Oct 2013
MULTISTIM
K132137 · Metron Medical Australia, Pty, Ltd. · Sep 2013
STIMEL-03
K130424 · Stimel, Ltd. · Jul 2013
EMPI PHOENIX
K124016 · Djo, LLC · May 2013
MUSCLE STIMULATION SYSTEM
K123642 · Niveus Medical, Inc. · Mar 2013
GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
K120922 · Selectivemed Components, Inc. · Feb 2013