K202979 is an FDA 510(k) clearance for the MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra. This device is classified as a Exerciser, Measuring (Class II - Special Controls, product code ISD).
Submitted by Lode B.V. (Groningen, NL). The FDA issued a Cleared decision on December 21, 2020, 82 days after receiving the submission on September 30, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5360.
| 510(k) Number | K202979 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2020 |
| Decision Date | December 21, 2020 |
| Days to Decision | 82 days |
| Submission Type | Abbreviated |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | ISD - Exerciser, Measuring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5360 |