Cleared Abbreviated

AVACEN 100

K133981 · Avacen, Inc. · Physical Medicine
Aug 2014
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K133981 is an FDA 510(k) clearance for the AVACEN 100, a Pad, Heating, Powered (Class II — Special Controls, product code IRT), submitted by Avacen, Inc. (San Diego, US). The FDA issued a Cleared decision on August 15, 2014, 232 days after receiving the submission on December 26, 2013. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5740.

Submission Details

510(k) Number K133981 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code IRT — Pad, Heating, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5740