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

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.

Clearance details

Applicant: Myolyn, LLC
Product code: Code GZI
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 ↗

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