MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra— 510(k) K202979

Substantially Equivalent

Lode B.V.

FDA 510(k) clearance K202979 for MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra, Substantially Equivalent on 2020-12-21. Applicant: Lode B.V..

Clearance details

Applicant: Lode B.V.
Product code: Code ISD
Advisory panel: Physical Medicine
Date received: 2020-09-30
Decision date: 2020-12-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Groningen, NL

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Adverse events under product code ISD

product code ISD

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.