MyoCycle MC-2 (Home / Home + / Pro / Pro +)— 510(k) K213925

Name: FDA 510(k) clearance K213925
Creator: U.S. Food and Drug Administration
Published: 2022-04-25

Substantially Equivalent

Myolyn, LLC

FDA 510(k) clearance K213925 for MyoCycle MC-2 (Home / Home + / Pro / Pro +), Substantially Equivalent on 2022-04-25. Applicant: Myolyn, LLC. Device class: 2.

Clearance details

Applicant: Myolyn, LLC
Product code: Code GZI
Device class: Class 2
Regulation: 21 CFR 882.5810
Advisory panel: Neurology
Date received: 2021-12-16
Decision date: 2022-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K213925

K-number listed on FDA's recall record

Z-1523-2022 — Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.Class II·Terminated·Myolyn Inc.·20220719

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213925.

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