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FDA 510(k)

Action Trackchair

K-Number: K181908 · 2018-12-03

ApplicantAction Manufacturing, Inc.
Decision Date2018-12-03
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Action Trackchair 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 2018-12-03 under 510(k) number K181908. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Action Trackchair?

Action Trackchair is a medical device that received FDA 510(k) clearance on 2018-12-03. The listed applicant is Action Manufacturing, Inc.. The 510(k) number is K181908.

When did Action Trackchair receive FDA 510(k) clearance?

Action Trackchair received FDA 510(k) clearance on 2018-12-03, under 510(k) number K181908.

Who is the listed applicant for Action Trackchair?

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 Trackchair?

The FDA product code for Action Trackchair is ITI.

Other records listing Action Manufacturing, Inc. 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.

K202728Action Trackchair HawkK163451Action Trackstander models TR1816, TR1820, TR2016, and TR2020

Related Devices (Code: ITI)

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.

K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance Co., Ltd.K261396Electric WheelchairNingbo Resshidi Medical Devices Co., Ltd.K261164Electric wheelchair (XW-LY007 )Yongkang Ruihe Metal Product Co., Ltd.K260937Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)Shanghai Waylong Intelligent Technology Co.,LtdK253812Power Wheelchair (W5915B, W5915C, W5915D)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260335Electric Wheelchair (S500-6)Zhongshan Sulenz Intelligent Technology Co., Ltd.

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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