Ortho-Therm Infrared Sensor

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

510(k) Number

K812701 ↗

FDA Product Code

IYM

Device Class

Class III

Regulation

21 CFR Part 884.2980

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Shower Stool W/Handles

  Class I

  FDA 510(k) K823154 Active Cleared 5 Nov 1982

• Mark V High Voltage Galvanic Stimulatorr

  Class II

  FDA 510(k) K832546 Active Cleared 14 Oct 1983

• Collapsable Lavatory Heightener

  Class I

  FDA 510(k) K823156 Active Cleared 5 Nov 1982

• Bath Tub Seat & Bath Board

  Class I

  FDA 510(k) K823153 Active Cleared 5 Nov 1982

• Ob Tilt Table

  Class I

  FDA 510(k) K823149 Active Cleared 5 Nov 1982

• Ob Help Arm

  Class I

  FDA 510(k) K823152 Active Cleared 5 Nov 1982

See all devices from Orthion Corp. →

• What clinical specialties is the Ortho-Therm Infrared Sensor primarily designed for, and how does it differ from traditional temperature measurement methods?

  The Ortho-Therm Infrared Sensor is specifically designed for obstetrics and gynecology applications, where non-invasive, remote temperature monitoring is required. Unlike traditional contact-based thermometers, it uses telethermographic infrared technology to measure body temperature without direct physical contact, reducing potential contamination risks and patient discomfort. This makes it ideal for settings where quick, hands-free assessments are needed, such as fetal or maternal physiological monitoring.

• Is the Ortho-TherM Infrared Sensor reusable, and if not, what are the implications for clinical workflows?

  The Ortho-TherM Infrared Sensor is single-use only, meaning each sensor is intended for one-time use in a single patient assessment. This design eliminates the need for reprocessing (e.g., cleaning or sterilization) between patients, reducing infection risks and operational complexity. Clinicians should plan for inventory management to ensure availability for multiple patients, as each sensor cannot be reused.

• What storage requirements does the Ortho-TherM Infrared Sensor have, and can it be used in environments with standard temperature controls?

  The Ortho-TherM Infrared Sensor does not require specialized storage conditions beyond standard environmental controls. It can be stored in typical clinical settings where temperature and humidity are regulated, such as examination rooms or supply closets. No refrigeration, sterilization, or additional handling is necessary before use, making it convenient for immediate deployment in obstetrics or gynecology clinics.

• How is the Ortho-TherM Infrared Sensor supplied, and does it come with any accessories or instructions?

  The Ortho-TherM Infrared Sensor is supplied as a disposable, single-use device in a packaged format suitable for clinical use. While the exact packaging details aren’t specified, its design as a standalone sensor implies it may include minimal accessories (e.g., a protective casing or attachment mechanism for the infrared system). Users should refer to the manufacturer’s instructions (provided by Orthion Corp.) for proper handling, calibration, and operational guidance, though no additional accessories like probes or cables are implied in the device description.

• Can the Ortho-TherM Infrared Sensor be used in MRI environments, and what considerations should clinicians keep in mind?

  The Ortho-TherM Infrared Sensor is not MRI-compatible, meaning it should not be used in or near MRI machines. Clinicians must ensure the sensor is only used in non-MRI settings, such as standard obstetrics or gynecology exam rooms. If temperature monitoring is required for patients who may later undergo MRI imaging, an alternative non-infrared method should be considered for those assessments.