Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Action Manufacturing, Inc.. It received FDA 510(k) clearance on 2018-01-12 under approval 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. It is manufactured by Action Manufacturing, Inc.. The 510(k) number is K163451.

When was Action Trackstander models TR1816, TR1820, TR2016, and TR2020 approved by the FDA?

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

What company makes Action Trackstander models TR1816, TR1820, TR2016, and TR2020?

Action Trackstander models TR1816, TR1820, TR2016, and TR2020 is manufactured by Action Manufacturing, Inc..

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.

Related Clinical Trials

NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT05110183 Opto-electrical Cochlear Implants ENROLLING_BY_INVITATION NCT07500103 Spatiotemporal Entrainment Neuromodulation Targeting Cerebello-Cerebral Circuits to Enhance Cognitive and Social Rehabilitation in Cerebellar Diseases RECRUITING

Other Devices by Action Manufacturing, Inc.

K181908Action Trackchair K202728Action Trackchair Hawk

Related Devices (Code: IPL)

K172384Quickie(r) Q700-UP MSunrise Medical (Us), LLC K191874F5 Corpus VSPermobil AB K182257UPnRIDEUpnride Robotics , Ltd. K191376Modular Power Standing SystemMotion Concepts K191334Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08Matia Robotics (Us), Inc. K190682Explorer MiniPermobil AB

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.

↑