RII Infrared Ear Thermometer, Model TH01BN
by Radiant Innovation Inc. Taiwan 510(k)
510(k) K070976 Product code FLL
Overview
The RII Infrared Ear Thermometer, Model TH01BN is an infrared ear thermometer classified under FDA product code FLL. It employs an infrared detector (thermopile detector) to measure body temperature non-invasively via the auditory canal, providing rapid readings for clinical use in general hospital settings.
This device is intended for single-use or reusable applications, depending on manufacturer guidelines, and is regulated under FDA 510(k) clearance (K070976) as substantially equivalent to existing technology. Supplied sterile or non-sterile based on packaging instructions, it requires proper storage to maintain accuracy and functionality. No specific MRI safety classification is stated in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070976 | Date20 Apr 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FLL
- FDA applicant
- Radiant Innovation, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Radiant Innovation Inc.
Questions
How is the RII Infrared Ear Thermometer (Model TH01BN) intended to be used in clinical settings, and what type of patients is it designed for?
The RII Infrared Ear Thermometer (Model TH01BN) is designed for non-invasive temperature measurement via the auditory canal, making it suitable for rapid clinical readings in general hospital settings. It employs infrared technology to detect body temperature without physical contact, which is particularly useful for patients who may be sensitive to traditional oral or rectal thermometers. The device is classified under FDA product code FLL, indicating its regulatory alignment with general hospital use cases.
Can the RII Infrared Ear Thermometer (Model TH01BN) be reused, or is it intended for single-use only?
The RII Infrared Ear Thermometer (Model TH01BN) is labeled as suitable for *either* single-use or reusable applications, depending on the manufacturer’s guidelines. If reused, proper cleaning and sterilization procedures must be followed to ensure accuracy and hygiene. The device’s sterility status depends on the packaging instructions provided, so always verify these before use to avoid contamination or performance issues.
What storage conditions should be followed to maintain the accuracy and functionality of the RII Infrared Ear Thermometer (Model TH01BN)?
The RII Infrared Ear Thermometer (Model TH01BN) requires proper storage to preserve its accuracy and functionality, though specific storage instructions are not detailed in the provided data. Generally, infrared thermometers should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. Avoid storing it in areas prone to dust or chemical fumes, as these can affect sensor performance over time.
Is the RII Infrared Ear Thermometer (Model TH01BN) compatible with MRI environments, or are there any safety concerns?
The provided data does not specify an MRI safety classification for the RII Infrared Ear Thermometer (Model TH01BN), meaning its compatibility with MRI environments is not confirmed. As a general precaution, avoid using electronic medical devices near MRI machines unless explicitly labeled as MRI-safe. If MRI compatibility is required, consult the manufacturer’s documentation or verify with Radiant Innovation Inc. for guidance.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K070976