# K202979: MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra

- Pathway: 510(k) (Abbreviated)
- Applicant: Lode B.V.
- Decided: Dec 21, 2020 after 82 days
- Product code: ISD (Exerciser, Measuring)
- Device class: 2
- Regulation: 21 CFR 890.5360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device is intended to be used as a stress test device in a medical environment. The main goal of the use of the devices is to create reproducible stress tests. With cycling ergometers typically workload (watt) is imposed. This product is designed both for manual operation and for control by external software. This device will be used in conjunction with another medical device to obtain other important physiological data, allowing a physician to evaluate a test subjects physical status.

Source page: https://510kreport.com/device/K202979
Methodology: https://510kreport.com/methodology