Hivox Ear Thermometer, TS Series
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K020471 FDA 510(k)
- FDA Product Code
- FLL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2910 FDA 510(k)
- Regulation Number
- 880.2910 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hivox Ear Thermometer, TS Series is a hand‑held infrared ear thermometer that measures tympanic temperature by detecting thermal radiation emitted from the ear canal with an infrared thermopile sensor and converting it to a digital reading. It provides non‑invasive temperature monitoring for personal health management.
The device is supplied as a reusable unit intended for home use by consumers. It is cleared under FDA 510(k) (K020471, product code FLL) and is not marketed as a sterile or single‑use product. No specific MRI safety or storage conditions are stated in the data provided.
Frequently asked questions
What temperature does the HIVOX TS Series measure and how?
It measures tympanic (ear canal) temperature by detecting infrared radiation emitted from the ear canal with a thermopile sensor and converting that signal into a digital reading, providing a non‑invasive estimate of core body temperature.
Is the HIVOX TS Series a single‑use or reusable device?
The TS Series is supplied as a reusable unit intended for repeated home use; it is not marketed as sterile or for single‑use applications, so users can clean it according to the manufacturer’s instructions between measurements.
How is the HIVOX TS Series provided to the consumer?
The thermometer is delivered as a complete hand‑held unit ready for immediate use in a household setting; no additional accessories or consumables are required for its basic temperature‑reading function.
Are there any special storage or safety requirements for this thermometer?
No specific storage conditions or MRI safety information are provided in the data, indicating that standard room‑temperature storage is acceptable and the device is not intended for use in magnetic environments.
What regulatory clearance does the HIVOX TS Series have?
The device is cleared under FDA 510(k) (K020471) with a traditional clearance pathway, indicating it is substantially equivalent to a legally marketed predicate device and may be marketed in the United States for home temperature monitoring.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HIVOX EAR THERMOMETER, TS SERIES (K020471) — FDA 510 (k) | Innolitics, Hivox Ear Thermometer, Ts Series 510 (k) FDA Premarket Notification ..., Hivox Biotek Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K020471 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hivox Biotek Inc.
- FDA Applicant
- Hivox Biotek, Inc.
Sources (1)
- FDA 510(k) K020471 24 fields · synced Sep 26, 2026