K112121 is an FDA 510(k) clearance for the ERGOSELECT/GE. This device is classified as 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 FDA review panel. Regulated under 21 CFR 890.5360.
| 510(k) Number | K112121 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | ISD - Exerciser, Measuring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5360 |