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

FDA 510(k) K240125 · Zenith Technical Innovations

Substantially Equivalent

510(k) numberK240125

Submission

Device name
Therm-X (Home); Therm-X (AT)
Applicant
Zenith Technical Innovations
Gurnee, IL, US
Received
January 16, 2024
Decision date
June 21, 2024
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JOW – Sleeve, Limb, Compressible
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5800
Specialty
Cardiovascular

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K254267NanoPress 760A-BT (760A-BT)JOW · Traditional Mego Afek , Ltd.02/24/2026SE
K250974Bio Arterial Deluxe (IC-BAP-DX)JOW · Traditional Bio Compression Systems, Inc.12/12/2025SE
K250190Sequential Compression System (SCD600)JOW · Traditional Shenzhen Comen Medical Instruments Co.,Ltd12/08/2025SE
K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System…JOW · Special Wellell, Inc.10/28/2025SE
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More from Manamed, LLC

510(k)DeviceDecision
K231912Therm-XIRP · Special 07/27/2023SE
K193550Therm-XIRP · Traditional 02/28/2020SE
K190854Therm-XIRP · Abbreviated 05/10/2019SE
K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteIRP · Traditional 08/03/2018SE

Questions and answers

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

Therm-X (Home); Therm-X (AT) (K240125) received a 510(k) decision of Substantially Equivalent on June 21, 2024, 157 days after the submission was received.

What is the product code of K240125?

The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.