Joinsoon High Speed Digital Thermometer, Model TC-001
by Joinsoon Electronics Mfg Co, Ltd. 510(k)
Active
510(k) K101232
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101232 | Date21 Jul 2010 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Joinsoon Electronics Mfg Co. Ltd High Speed Digital Thermometer, Model Tc-001
- 510(k) Number
- FDA Product Code
- FLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Joinsoon High Speed Digital Thermometer, Model TC-001, is an electronic clinical thermometer designed to measure human body temperature. It employs a thermistor sensor to provide rapid and accurate readings, suitable for both clinical and home use. This device falls under the classification of electronic clinical thermometers, as defined by regulatory standards.
The thermometer is intended for single-use or reusable applications in general hospital settings, depending on manufacturer guidelines. It operates in both clinical and home environments, allowing patients or clinicians to measure oral or rectal temperature. The device is FDA-cleared under 510(k) number K101232, with a classification under product code FLL and regulatory classification 880.2910. Storage and handling instructions are not specified but should follow standard practices for electronic medical devices.
Other devices from Joinsoon Electronics Mfg Co, Ltd.
Questions
AI-generated answers, 20 Sep 2026
Can this thermometer be used in both clinical and home settings, and what temperature measurement methods does it support?
Yes, the Joinsoon High Speed Digital Thermometer (Model TC-001) is designed for use in both clinical and home environments. It measures human body temperature via two methods: oral (mouth) and rectal routes, providing flexibility for different patient needs. The device’s rapid-read thermistor sensor ensures quick and accurate results in either setting.
Is the thermometer intended for single-use or reusable applications, and how should it be handled?
The Joinsoon TC-001 is approved for both single-use and reusable applications, depending on facility guidelines. While the device itself isn’t explicitly labeled as disposable, its clinical-grade design allows for reuse if properly cleaned and maintained per manufacturer protocols. Standard electronic medical device handling practices should be followed, though specific storage or sterilization instructions aren’t detailed in the submission.
What regulatory pathway was followed for FDA clearance, and what does the product code (FLL) indicate about its intended use?
The thermometer received FDA clearance via a 510(k) submission (K101232) under the Special 510(k) Review pathway, classified as *Substantially Equivalent* to a predicate device. The product code FLL (Fever/Low Temperature) aligns with its primary function: measuring body temperature for fever detection or monitoring low-temperature conditions, though it doesn’t specify clinical indications beyond general temperature assessment.
How quickly does this thermometer provide temperature readings, and what type of sensor does it use?
The thermometer’s name includes ‘High Speed,’ implying it delivers rapid readings compared to traditional analog devices. While exact response time isn’t specified in the data, its thermistor sensor technology is known for quick thermal conductivity, making it suitable for clinical settings where efficiency matters. The oral/rectal probes are likely designed to minimize measurement delay.
Are there multiple models or sizes available for the TC-001, or is it a single unified device?
The provided data only references one model (TC-001), with no mention of variants, probe sizes, or additional configurations. It appears as a unified device for oral and rectal use, though the absence of size details suggests it may not accommodate pediatric-specific probes or adult-only adaptations. Always verify local inventory for available options.