Cleared Traditional

K053078 - ERGOSELECT 100 K/P, ERGOSELECT 200 K/P
(FDA 510(k) Clearance)

K053078 · Ergoline GmbH · Physical Medicine

Apr 2006

Decision

176d

Days

Class 2

Risk

K053078 is an FDA 510(k) clearance for the ERGOSELECT 100 K/P, ERGOSELECT 200 K/P, a Exerciser, Measuring (Class II — Special Controls, product code ISD), submitted by Ergoline GmbH (Bitz, B-W, DE). The FDA issued a Cleared decision on April 27, 2006, 176 days after receiving the submission on November 2, 2005. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5360.

Submission Details

510(k) Number	K053078 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 2005
Decision Date	April 27, 2006
Days to Decision	176 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF