FDA 510(k)

Therm-X (Home); Therm-X (AT)

K-Number: K240125 · 2024-06-21

Decision Date2024-06-21

Product CodeJOW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Therm-X (Home); Therm-X (AT) is a medical device manufactured by Zenith Technical Innovations. It received FDA 510(k) clearance on 2024-06-21 under approval number K240125. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Therm-X (Home); Therm-X (AT)?

Therm-X (Home); Therm-X (AT) is a medical device that received FDA 510(k) clearance on 2024-06-21. It is manufactured by Zenith Technical Innovations. The 510(k) number is K240125.

When was Therm-X (Home); Therm-X (AT) approved by the FDA?

Therm-X (Home); Therm-X (AT) received FDA 510(k) clearance on 2024-06-21, under approval number K240125.

What company makes Therm-X (Home); Therm-X (AT)?

Therm-X (Home); Therm-X (AT) is manufactured by Zenith Technical Innovations.

What is the FDA product code for Therm-X (Home); Therm-X (AT)?

The FDA product code for Therm-X (Home); Therm-X (AT) is JOW.

Other Devices by Zenith Technical Innovations

K181149Therm-X Pro, Therm-X AT, Therm-X Pro Athlete K190854Therm-X K193550Therm-X K231912Therm-X

Related Devices (Code: JOW)

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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.