Graphic Stress Telethermometry System

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Graphic Stress Telethermometry

510(k) Number

K800491 ↗

FDA Product Code

IYM

Device Class

Class III

Regulation

21 CFR Part 884.2980

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESP Substantially Equivalent — Postmarket Surveillance

• Gst System Thermographic Application

  Class I

  FDA 510(k) K842878 Active Cleared 22 Mar 1985

• What clinical setting or specialty is the Graphic Stress Telethermometry System primarily used in, and how does it work?

  The Graphic Stress Telethermometry System is designed for use in clinical settings within obstetrics and gynecology, where it aids in diagnostic assessments. It operates using infrared technology to measure surface heat non-invasively. By capturing thermal emissions, the device generates graphical representations of stress-related physiological changes, helping clinicians evaluate patient responses without direct contact.

• Is the Graphic Stress Telethermometry System intended for single-use or reusable applications, and what does that mean for maintenance?

  The Graphic Stress Telethermometry System is explicitly described as a reusable medical device, meaning it is not designed for single-use. This implies that after use, the device must be cleaned, disinfected, and maintained according to manufacturer guidelines to ensure accuracy and safety for subsequent clinical applications. No sterility designation is noted, so proper reprocessing protocols are critical.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Graphic Stress Telethermometry System received FDA 510(k) clearance under the traditional review pathway, as indicated by clearance number K800491. It is classified as a Class III device under regulation number 884.2980, which typically requires stringent premarket approval due to its role in diagnostic assessments. The review was handled by the Obstetrics/Gynecology (OB) advisory committee.

• How is the device supplied, and are there any specific storage requirements mentioned in the available data?

  The Graphic Stress Telethermometry System is supplied as a reusable medical device, meaning it is intended for repeated use in clinical environments. While the data does not specify detailed storage requirements, reusable devices generally require protection from environmental factors like moisture, extreme temperatures, and physical damage. Manufacturers typically provide guidelines for storage conditions to maintain device performance and longevity.