Data / Medical devices / Taiwan / Fortechgrp Co., Ltd.
Fortechgrp Co., Ltd.: FDA-registered device maker in Taoyuan city, Taiwan, 1 510(k) clearance
Fortechgrp Co., Ltd. is registered with the FDA (registration 3016509757) in Taoyuan city, Taiwan. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 8, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016509757
- Address
- No.62, Dingxing Rd., Guishan Dist., Taoyuan city, Taiwan, 33345
- Owner or operator
- FORTECHGRP CO., LTD. (10059155)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 12, 2019
- Registered through
- 2026
- Brand names listed
- 9 SEC FLEX TIP DIG THERMOM FAHRENHEIT (VERTICAL PACKAGE), 9 SECOND DIGITAL THERMOMETER FAHRENHEIT, Fore Health Forehead and Ear Infrared Thermometer ACT8000-F, Fore Health Smart Ear Thermometer ACT8000-TB,ACT8000-TG, Fore Health Smart Thermometer GAL05Ex-XX/BC, ForeHealth digital clinical thermometer, MABIS - 9 SECOND FLEXIBLE TIP DIGITAL THERMOMETER FAHRENHEIT, RightTemp Ear thermometer and Probe Cover and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 8, 2007 | K070028 | CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER | FLL | Substantially Equivalent | Actherm, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 8, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.