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

Name: FDA 510(k) clearance K202979
Creator: U.S. Food and Drug Administration
Published: 2020-12-21

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.. Device class: 2.

Clearance details

Applicant: Lode B.V.
Product code: Code ISD
Device class: Class 2
Regulation: 21 CFR 890.5360
Advisory panel: Physical Medicine
Date received: 2020-09-30
Decision date: 2020-12-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Groningen, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code ISD

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K143512 — ActiSpec Activity Monitor2015-08-26
K112121 — ERGOSELECT/GE2012-10-31
K080545 — ACTITRAINER2008-07-24
K053078 — ERGOSELECT 100 K/P, ERGOSELECT 200 K/P2006-04-27

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.