FDA 510(k)

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

K-Number: K213925 · 2022-04-25

Decision Date2022-04-25

Product CodeGZI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MyoCycle MC-2 (Home / Home + / Pro / Pro +) is a medical device manufactured by Myolyn, LLC. It received FDA 510(k) clearance on 2022-04-25 under approval number K213925. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MyoCycle MC-2 (Home / Home + / Pro / Pro +)?

MyoCycle MC-2 (Home / Home + / Pro / Pro +) is a medical device that received FDA 510(k) clearance on 2022-04-25. It is manufactured by Myolyn, LLC. The 510(k) number is K213925.

When was MyoCycle MC-2 (Home / Home + / Pro / Pro +) approved by the FDA?

MyoCycle MC-2 (Home / Home + / Pro / Pro +) received FDA 510(k) clearance on 2022-04-25, under approval number K213925.

What company makes MyoCycle MC-2 (Home / Home + / Pro / Pro +)?

MyoCycle MC-2 (Home / Home + / Pro / Pro +) is manufactured by Myolyn, LLC.

What is the FDA product code for MyoCycle MC-2 (Home / Home + / Pro / Pro +)?

The FDA product code for MyoCycle MC-2 (Home / Home + / Pro / Pro +) is GZI.

Other Devices by Myolyn, LLC

K170132MyoCycle Home, MyoCycle Pro

Related Devices (Code: GZI)

K153163ReGraspRehabtronics, Inc. K162718Foot Drop System (Model XFT-2001D)Shenzhen Xft Medical Limited K170564MyndMove System, MyndMove Functional Electrical StimulatorMyndtec, Inc. K162470RT300 FES cycle ergometerRestorative Therapies, Inc. K170132MyoCycle Home, MyoCycle ProMyolyn, LLC K162683RehaStim 2Hasomed GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.