Action Trackstander models TR1816, TR1820, TR2016, and TR2020— 510(k) K163451

Name: FDA 510(k) clearance K163451
Creator: U.S. Food and Drug Administration
Published: 2018-01-12

Substantially Equivalent

Action Manufacturing, Inc.

FDA 510(k) clearance K163451 for Action Trackstander models TR1816, TR1820, TR2016, and TR2020, Substantially Equivalent on 2018-01-12. Applicant: Action Manufacturing, Inc.. Device class: 2.

Clearance details

Applicant: Action Manufacturing, Inc.
Product code: Code IPL
Device class: Class 2
Regulation: 21 CFR 890.3900
Advisory panel: Physical Medicine
Date received: 2016-12-08
Decision date: 2018-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marshall, MN, US

Download summary PDF View on FDA.gov ↗

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