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FDA 510(k)

MyoCycle Home, MyoCycle Pro

K-Number: K170132 · 2017-04-25

ApplicantMyolyn, LLC
Decision Date2017-04-25
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MyoCycle Home, MyoCycle Pro is a medical device manufactured by Myolyn, LLC. It received FDA 510(k) clearance on 2017-04-25 under approval number K170132. 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 Home, MyoCycle Pro?

MyoCycle Home, MyoCycle Pro is a medical device that received FDA 510(k) clearance on 2017-04-25. It is manufactured by Myolyn, LLC. The 510(k) number is K170132.

When was MyoCycle Home, MyoCycle Pro approved by the FDA?

MyoCycle Home, MyoCycle Pro received FDA 510(k) clearance on 2017-04-25, under approval number K170132.

What company makes MyoCycle Home, MyoCycle Pro?

MyoCycle Home, MyoCycle Pro is manufactured by Myolyn, LLC.

What is the FDA product code for MyoCycle Home, MyoCycle Pro?

The FDA product code for MyoCycle Home, MyoCycle Pro is GZI.

Other Devices by Myolyn, LLC

K213925MyoCycle MC-2 (Home / Home + / Pro / Pro +)

Related Devices (Code: GZI)

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Official Source

View on FDA Database →

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

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