Therm-X Pro, Therm-X AT, Therm-X Pro Athlete— 510(k) K181149

Name: FDA 510(k) clearance K181149
Creator: U.S. Food and Drug Administration
Published: 2018-08-03

Substantially Equivalent

Zenith Technical Innovations

FDA 510(k) clearance K181149 for Therm-X Pro, Therm-X AT, Therm-X Pro Athlete, Substantially Equivalent on 2018-08-03. Applicant: Zenith Technical Innovations. Device class: 2.

Clearance details

Applicant: Zenith Technical Innovations
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2018-05-01
Decision date: 2018-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gurnee, IL, US

Download summary PDF View on FDA.gov ↗

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