Cleared Abbreviated

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

K202979 · Lode B.V. · Physical Medicine
Dec 2020
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

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, 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 review panel. Regulated under 21 CFR 890.5360.

Submission Details

510(k) Number K202979 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code ISD — Exerciser, Measuring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5360