Therm-X— 510(k) K190854

Substantially Equivalent

Zenith Technical Innovations

FDA 510(k) clearance K190854 for Therm-X, Substantially Equivalent on 2019-05-10. 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: 2019-04-02
Decision date: 2019-05-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Gurnee, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Zenith Technical Innovations

K240125 — Therm-X (Home); Therm-X (AT)2024-06-21
K231912 — Therm-X2023-07-27
K193550 — Therm-X2020-02-28
K181149 — Therm-X Pro, Therm-X AT, Therm-X Pro Athlete2018-08-03

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