510(k) K053078

ERGOSELECT 100 K/P, ERGOSELECT 200 K/P by Ergoline GmbH — Product Code ISD

K053078 is an FDA 510(k) premarket notification submitted by Ergoline GmbH for the device "ERGOSELECT 100 K/P, ERGOSELECT 200 K/P". The FDA issued a decision of Substantially Equivalent on April 27, 2006. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360. Ergoline GmbH has at least 2 other 510(k) clearances on record.