Cleared Abbreviated

K133981 - AVACEN 100

K133981 is an FDA 510(k) clearance for AVACEN 100, manufactured by Avacen, Inc.. The device is a Class 2 Physical Medicine device with product code IRT cleared through the Abbreviated 510(k) pathway after a 232-day FDA review.

K133981 · Avacen, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
232d
Days
Class 2
Risk

K133981 is an FDA 510(k) clearance for the AVACEN 100. Classified as Pad, Heating, Powered (product code IRT), Class II - Special Controls.

Submitted by Avacen, Inc. (San Diego, US). The FDA issued a Cleared decision on August 15, 2014 after a review of 232 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5740 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K133981

510(k) Number K133981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2013
Decision Date August 15, 2014
Days to Decision 232 days
Submission Type Abbreviated
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
116d slower than avg
Panel avg: 116d · This submission: 232d
Pathway characteristics
Standards-based clearance path.

IRT Device Classification - Class 2, Special Controls

Product Code IRT Pad, Heating, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Physical Medicine devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01619579 Completed Interventional Industry-sponsored

Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain

Effects of a 4 Week AVACEN Treatment on Pain Perception in Fibromyalgia - An Open Label Study

22
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Fibromyalgia
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Avacen, Inc. (industry)
Started 2011-06-01 → Primary completion 2012-05-01 → Completed 2013-05-01
Primary outcome
Widespread Pain Index (WPI) Score After 4 Weeks Treatment
View full study on ClinicalTrials.gov

Regulatory Peers - IRT Pad, Heating, Powered

All 30
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K133981 · AVACEN 100
Download PDF FDA Summary Avacen, Inc.