FDA 510(k)

MyoCycle Home, MyoCycle Pro

K-Number: K170132 · 2017-04-25

Decision Date2017-04-25

Product CodeGZI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MyoCycle Home, MyoCycle Pro is the device name listed in this FDA 510(k) record. The listed applicant is Myolyn, LLC. It received FDA 510(k) clearance on 2017-04-25 under 510(k) 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. The listed applicant is Myolyn, LLC. The 510(k) number is K170132.

When did MyoCycle Home, MyoCycle Pro receive FDA 510(k) clearance?

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

Who is the listed applicant for MyoCycle Home, MyoCycle Pro?

The FDA 510(k) record lists Myolyn, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Myolyn, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

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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.