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Infrared Thermometer HW-1

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K211583

by Dongguan SIMZO Electronic Technology Co., Ltd.

Identifiers

510(k) Number
K211583 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 Infrared Thermometer HW-1 is a non-contact temperature measurement device designed to measure body temperature via infrared radiation. It falls under the category of infrared thermometers, which detect thermal energy emitted by the skin without physical contact, providing rapid and precise readings for clinical use.

This device is intended for single-use in general hospital settings, as indicated by its advisory committee classification. Supplied sterile, the HW-1 is regulated under FDA 510(k) clearance (K211583), MDD, and MDR compliance. It is not MRI-safe and requires proper storage in a clean, dry environment to maintain accuracy and sterility.

Frequently asked questions

Is the HW-1 infrared thermometer designed for repeated use in clinical settings, or is it meant to be used only once per patient?

The HW-1 is explicitly classified for single-use in general hospital settings, as noted in its advisory committee classification. This design ensures hygiene and reduces cross-contamination risks, making it ideal for clinical environments where sterility is critical.

How should I store the HW-1 thermometer to keep it accurate and sterile until use?

The device must be stored in a clean, dry environment to preserve both its accuracy and sterility. Since it is supplied sterile and intended for single-use, avoid exposure to moisture, dust, or extreme temperatures, which could compromise performance or integrity before use.

Can the HW-1 infrared thermometer be used inside an MRI scanner, or does it have any MRI-related restrictions?

The HW-1 is not MRI-safe, meaning it should not be used or stored near MRI equipment. This is explicitly stated in the device description, so clinicians must ensure it is kept away from magnetic fields to prevent interference or damage.

What regulatory pathways does the HW-1 follow, and how does that affect its use in different markets?

The HW-1 is cleared under FDA 510(k) (K211583) and complies with MDD (Medical Device Directive) and MDR (Medical Device Regulation) standards. This means it is approved for use in the U.S. and the EU, but buyers should verify local compliance requirements, as regulations may vary by country or region.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dongguan SIMZO Electronic Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K211583 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026