Fond Non-Contact Infrared Thermometer
Fond Non-contact Infrared Thermometer measures body temperature from infrared heat emitted at the center of the forehead. It is a reusable handheld device for people aged two months and…
Fond Non-contact Infrared Thermometer measures body temperature from infrared heat emitted at the center of the forehead. It is a reusable handheld device for people aged two months and older, intended for consumer home use or clinical reference. Measurement is taken from 15 to 50 mm away.
The AET-R161, AET-R171, AET-R1D2 and AET-R1B1 models show readings on a backlit LCD in Celsius or Fahrenheit and retain 32 readings. They provide a sound alert for elevated temperature, a low-battery indicator and automatic power-off after more than 60 seconds idle.
Model-Specific Data Transfer
The AET-R161 connects to the FOND mobile app by Bluetooth so measurements can be recorded, saved and shared. The other described models do not include this data-transfer function. The thermometer range is supplied nonsterile, and available visual high-temperature indications vary by model.
Who Else Makes It
Concentrated in Guangdong (68), Zhejiang (15), Jiangsu (13). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Zhejiang Hongyu Medical Commodity Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 36 |
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Famidoc Technology Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 9 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Tasco Medical Industries Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 6 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Betacera Inc. | Suzhou | Jiangsu | Contract manufacturer | 3 |
Showing 12 of 115. All 115 manufacturers in China registered for Continuous Measurement Thermometer
Record
| Listed by | Alicn Medical Shenzhen, Inc, China |
|---|---|
| FDA product code | FLL |
| Device type | Continuous Measurement Thermometer |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2910 |
| Establishment | Manufacturer |
| 510(k) | K180207 |
| Record published | 2019-04-20 |
| Record revised | 2020-12-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AET-R1D2 | In distribution | |
| AET-R161 | In distribution | |
| AET-R171 | In distribution | |
| AET-R1D1 | In distribution | |
| AET-R1B1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 434 |
| Safety 1st | Dorel Juvenile Group, Inc. | 180 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 66 |
| Diagnostix™ | American Diagnostic Corp. | 61 |
| DeRoyal | Deroyal Industries, Inc. | 58 |
| Braun | KAZ USA, Inc. | 53 |
| Exergen Temporal Scanner | Exergen Corporation | 50 |
| Level 1 | ICU Medical, Inc | 48 |
| Famidoc | Famidoc Technology Co., Ltd. | 47 |
| Adtemp™ | American Diagnostic Corp. | 35 |
| TempTraq | Blue Spark Technologies, Inc. | 35 |
| Medline | Medline Industries, Inc. | 34 |
Showing 12 of 843. All products under Continuous Measurement Thermometer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232338 | 2023-12-22 |
| K222248 | 2023-06-07 |
| K210937 | 2022-05-12 |
| K210565 | 2022-05-05 |
| K212257 | 2022-05-04 |
| K210564 | 2022-01-07 |
| K180207 | 2018-11-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.