Pro Comfort Tempa Check 4-in-1 Infrared Thermometer

Medical thermometer for measuring ear/ forehead/ object temperature/ ambient temperature of human body via infrared rays emitted from the eardrum and skin surface. Measuring range:…

Registry build 21.09.26

Medical thermometer for measuring ear/ forehead/ object temperature/ ambient temperature of human body via infrared rays emitted from the eardrum and skin surface. Measuring range: 32.0-42.9°C (89.6-109.2°F)

115manufacturers in China registered for this device type
1catalogue number

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 Pro Comfort Tempa Check 4-in-1 Infrared thermometer
Listed by Home Aide Diagnostics, Inc., United States
FDA product code FLL
Device type Continuous Measurement Thermometer
Device class Class 2
Regulation 21 CFR 880.2910
Establishment Repacker / relabeller
510(k) K181215
Record published 2020-02-27

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment humidity 0 to 95 % RH; Handling environment atmospheric pressure -13 to 131 °F; Storage environment atmospheric pressure -25 to 55 °C; Handling environment humidity 20 to 95 % RH; Handling environment atmospheric pressure 59 to 104 °F; Handling environment temperature 15 to 40 °C
Packaging Inner case of 50, outer carton of 2

Catalogue Numbers

Catalogue numbers for Pro Comfort Tempa Check 4-in-1 Infrared thermometer
Catalogue number Size Status
10059798 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

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