Action Trackchair— 510(k) K181908

Substantially Equivalent

Action Manufacturing, Inc.

FDA 510(k) clearance K181908 for Action Trackchair, Substantially Equivalent on 2018-12-03. Applicant: Action Manufacturing, Inc..

Clearance details

Applicant: Action Manufacturing, Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2018-07-17
Decision date: 2018-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marshall, MN, US

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Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.