Infrared Thermometer

The Pango Infrared Thermometer family measures body temperature using infrared sensing. The PG-IRT1601 measures in the ear canal, the PG-IRT1602 measures the forehead, and the PG-IRT1603…

Registry build 21.09.26

The Pango Infrared Thermometer family measures body temperature using infrared sensing. The PG-IRT1601 measures in the ear canal, the PG-IRT1602 measures the forehead, and the PG-IRT1603 supports both ear and forehead measurements.

These handheld devices are reusable and battery powered. Their sensor measures the target, surrounding environment and sensor temperature, and the internal processor uses those signals to calculate the body temperature shown on the display.

Forehead Measurement

The forehead models use a measurement distance of 3 to 5 cm. The thermometer family is intended for people of all ages; the measurement site depends on the selected model.

115manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance

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.

Chinese manufacturers registered for FDA product code FLL
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

Regulatory record for Infrared Thermometer
Listed by Shenzhen Pango Electronic Co., Ltd., China
FDA product code FLL
Device type Continuous Measurement Thermometer
Device class Class 2
Regulation 21 CFR 880.2910
510(k) K182597
Record published 2020-04-17

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Infrared Thermometer
Catalogue number Size Status
PG-IRT1603 In distribution
PG-IRT1602 In distribution
PG-IRT1601 In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
Clearance Decision date
K182597 2019-04-03

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer