Flext-Therm
by E-Z-Em, Inc. 510(k)
Active
510(k) K781916
Overview
The Flex-Therm is a Thermographic Liquid Crystal System (KXZ, K781916) classified under FDA regulation 884.2982 as a Class III device. It employs liquid crystal technology to measure and display thermal patterns, serving as an adjunctive tool in obstetrics and gynecology for non-invasive temperature assessment.
This powered system is designed for single-use applications in clinical settings, requiring no sterilization between uses. Supplied as a complete kit, it adheres to FDA clearance (510K, K781916) and is intended for use in environments where thermal imaging aids diagnostic evaluation. No MRI safety data is specified, and storage conditions are not detailed in the regulatory submission.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781916 | Date2 Feb 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KXZ
- Device Class
- Class III
- Regulation
- 21 CFR Part 884.2982
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from E-Z-Em, Inc.
Questions
What clinical specialties is the Flex-Therm primarily intended for, and how does it assist in patient evaluation?
The Flex-Therm is designed for use in obstetrics and gynecology as an adjunctive tool. It employs liquid crystal technology to measure and display thermal patterns non-invasively, aiding in diagnostic evaluations where temperature assessment may be relevant. While it doesn’t replace traditional diagnostic methods, it provides additional thermal data to support clinical decision-making in these specialties.
Is the Flex-Therm reusable, or is it meant for single-use only? How does this impact clinical workflow?
The Flex-Therm is explicitly designed for single-use applications in clinical settings, eliminating the need for sterilization between uses. This simplifies workflow by reducing preparation time and ensuring hygiene, as each kit is pre-packaged and ready for immediate use without reprocessing.
What does the term ‘powered system’ mean for the Flex-Therm, and does it require any special handling during use?
The ‘powered system’ designation indicates the Flex-Therm requires an external power source to operate, likely electricity or batteries, to activate its liquid crystal technology for thermal imaging. Clinicians should ensure the device is properly powered and follow manufacturer instructions for safe operation, though no specific handling precautions (like MRI safety) are noted in the regulatory data.
Are there multiple sizes or models of the Flex-Therm, or is it available in a single configuration?
The provided data does not specify multiple sizes or models for the Flex-Therm; it is described as a single system (Thermographic, Liquid Crystal, Powered) under product code KXZ. If variations exist, they would not be reflected in the regulatory submission details shared.
How is the Flex-Therm supplied, and what should clinicians expect to receive in the kit?
The Flex-Therm is supplied as a complete kit, though the exact contents (e.g., probes, sensors, or accessories) aren’t detailed in the regulatory data. Typically, single-use kits include all necessary components for one procedure, ensuring no additional sterilization or assembly is required before use. Clinicians should confirm the kit’s contents with the manufacturer.