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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 a medical device manufactured by Myoworx, Inc.. It received FDA 510(k) clearance on 2021-10-19 under approval 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. It is manufactured by Myoworx, Inc.. The 510(k) number is K192746.

When was MyoWorx TM20 approved by the FDA?

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

What company makes MyoWorx TM20?

MyoWorx TM20 is manufactured by Myoworx, Inc..

What is the FDA product code for MyoWorx TM20?

The FDA product code for MyoWorx TM20 is IPF.

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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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