Cleared Traditional

ERGOSELECT/GE

K112121 · Ergoline GmbH · Physical Medicine

Oct 2012

Decision

464d

Days

Class 2

Risk

About This 510(k) Submission

K112121 is an FDA 510(k) clearance for the ERGOSELECT/GE, a Exerciser, Measuring (Class II — Special Controls, product code ISD), submitted by Ergoline GmbH (Tuttlingen, Baden Wurttemberg, DE). The FDA issued a Cleared decision on October 31, 2012, 464 days after receiving the submission on July 25, 2011. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5360.

Submission Details

510(k) Number	K112121 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2011
Decision Date	October 31, 2012
Days to Decision	464 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF