Cleared Traditional

MyoCycle MC-2 (Home / Home + / Pro / Pro +)

K213925 · Myolyn, LLC · Neurology
Apr 2022
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K213925 is an FDA 510(k) clearance for the MyoCycle MC-2 (Home / Home + / Pro / Pro +), a Stimulator, Neuromuscular, External Functional (Class II — Special Controls, product code GZI), submitted by Myolyn, LLC (Gainesville, US). The FDA issued a Cleared decision on April 25, 2022, 130 days after receiving the submission on December 16, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5810.

Submission Details

510(k) Number K213925 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2021
Decision Date April 25, 2022
Days to Decision 130 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZI — Stimulator, Neuromuscular, External Functional
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5810