K053078 is an FDA 510(k) clearance for the ERGOSELECT 100 K/P, ERGOSELECT 200 K/P. This device is classified as 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 FDA review panel. Regulated under 21 CFR 890.5360.
| 510(k) Number | K053078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | ISD - Exerciser, Measuring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5360 |