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FDA 510(k)

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

K-Number: K240125 · 2024-06-21

ApplicantZenith Technical Innovations
Decision Date2024-06-21
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Therm-X (Home); Therm-X (AT) is the device name listed in this FDA 510(k) record. The listed applicant is Zenith Technical Innovations. It received FDA 510(k) clearance on 2024-06-21 under 510(k) 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. The listed applicant is Zenith Technical Innovations. The 510(k) number is K240125.

When did Therm-X (Home); Therm-X (AT) receive FDA 510(k) clearance?

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

Who is the listed applicant for Therm-X (Home); Therm-X (AT)?

The FDA 510(k) record lists Zenith Technical Innovations as the applicant. This does not by itself establish the device manufacturer.

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 records listing Zenith Technical Innovations as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231912Therm-XK193550Therm-XK190854Therm-XK181149Therm-X Pro, Therm-X AT, Therm-X Pro Athlete

Related Devices (Code: JOW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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