Topcare
A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature from the temple. The device has an LCD display. It is designed to take a temperature…
A hand-held, battery-powered, electronic instrument designed to measure a patient’s body temperature from the temple. The device has an LCD display. It is designed to take a temperature reading in approximately 5 seconds. This is a reusable device.
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 | Topco Associates, LLC |
|---|---|
| FDA product code | FLL |
| Device type | Continuous Measurement Thermometer |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2910 |
| 510(k) | K041516 |
| Record published | 2016-09-13 |
| Record revised | 2025-07-07 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, serial number |
| Packaging | Inner/master carton of 48, master carton of 12, intermediate of 4, master carton of 36, intermediate of 3, master carton of 24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 87-705-000 | 5 | In distribution | |
| 52-363 | In distribution | ||
| 87-935-000 | In distribution | ||
| 52-348 | In distribution | ||
| 87-736-001 | In distribution | ||
| 87-691-001 | In distribution | ||
| DTT-1 | In distribution | ||
| 52-330 | In distribution | ||
| 87-207-000 | In distribution | ||
| 87-695-000 | In distribution | ||
| 52-304 | In distribution | ||
| 52-341 | In distribution | ||
| 87-621-000 | In distribution | ||
| 87-605-001 | In distribution | ||
| 52-309 | In distribution | ||
| 87-930-004 | 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
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Philips Consumer Lifestyle | 510(k) number | 2018-02-02 | Class II | Use error | Device may provide inaccurate measurements. | 45141 | 2019-03-29 |
| Walgreen Co. | 510(k) number | 2011-11-23 | Not classified | Labeling design | The thermometers have been reported to have inaccurate readings | estimated 92,000 units | 2017-08-14 |
| Omron Healthcare, Inc. | 510(k) number | 2005-10-25 | Not classified | Other | Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip. | Approximately 48,000 units | 2007-11-28 |
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.