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FDA 510(k)

Action Trackstander models TR1816, TR1820, TR2016, and TR2020

K-Number: K163451 · 2018-01-12

ApplicantAction Manufacturing, Inc.
Decision Date2018-01-12
Product CodeIPL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Action Trackstander models TR1816, TR1820, TR2016, and TR2020 is the device name listed in this FDA 510(k) record. The listed applicant is Action Manufacturing, Inc.. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K163451. The device is classified under product code IPL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Action Trackstander models TR1816, TR1820, TR2016, and TR2020?

Action Trackstander models TR1816, TR1820, TR2016, and TR2020 is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Action Manufacturing, Inc.. The 510(k) number is K163451.

When did Action Trackstander models TR1816, TR1820, TR2016, and TR2020 receive FDA 510(k) clearance?

Action Trackstander models TR1816, TR1820, TR2016, and TR2020 received FDA 510(k) clearance on 2018-01-12, under 510(k) number K163451.

Who is the listed applicant for Action Trackstander models TR1816, TR1820, TR2016, and TR2020?

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

What is the FDA product code for Action Trackstander models TR1816, TR1820, TR2016, and TR2020?

The FDA product code for Action Trackstander models TR1816, TR1820, TR2016, and TR2020 is IPL.

Other records listing Action Manufacturing, Inc. as applicant

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Official Source

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