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FDA 510(k)

MyoWorx TM20

K-Number: K192746 · 2021-10-19

ApplicantMyoworx, Inc.
Decision Date2021-10-19
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MyoWorx TM20 is the device name listed in this FDA 510(k) record. The listed applicant is Myoworx, Inc.. It received FDA 510(k) clearance on 2021-10-19 under 510(k) number K192746. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MyoWorx TM20?

MyoWorx TM20 is a medical device that received FDA 510(k) clearance on 2021-10-19. The listed applicant is Myoworx, Inc.. The 510(k) number is K192746.

When did MyoWorx TM20 receive FDA 510(k) clearance?

MyoWorx TM20 received FDA 510(k) clearance on 2021-10-19, under 510(k) number K192746.

Who is the listed applicant for MyoWorx TM20?

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

What is the FDA product code for MyoWorx TM20?

The FDA product code for MyoWorx TM20 is IPF.

Related Devices (Code: IPF)

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.

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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.

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