Data / Medical devices / China / Zhongshan Transtek Electronics Co., Ltd
Zhongshan Transtek Electronics Co., Ltd: FDA-registered device maker in Zhongshan Guangdong, China, 1 510(k) clearance
Zhongshan Transtek Electronics Co., Ltd is registered with the FDA (registration 3008485370) in Zhongshan Guangdong, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 30, 2013. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008485370
- Address
- Zone E, No. 105, Dongli Road Torch Development District, Zhongshan Guangdong, China, 528437
- Owner or operator
- Guangdong Transtek Medical Electronics Co., Ltd (10032922)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 17, 2012
- Registered through
- 2027
- Brand names listed
- 1169-05, BS-2001-G1, BT006, EZFAST Body Fat Analyzer, GBF-2108-B, GBF-2008-B1, GBF-2008-B3, GBS-2104-G, R.P.M. PRO Digital Weight Scale, Model:210-1113B and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition | MNW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Analyzer, Body Composition, Exempt | PUH | 2 | Manufacturer | accessdata.fda.gov |
| Device, Galvanic Skin Response Measurement | GZO | 2 | Contract manufacturer | accessdata.fda.gov |
| Scale, Patient | FRW | 1 | Manufacturer | accessdata.fda.gov |
| Scale, Stand-On, Patient | FRI | 1 | 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 |
|---|---|---|---|---|---|---|
| May 30, 2013 | K130311 | TRANSTEK BODY FAT ANALYZER | MNW | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Body Composition, Exempt
- All makers of Analyzer, Body Composition
- All makers of Device, Galvanic Skin Response Measurement
- All makers of Scale, Patient
- All makers of Scale, Stand-On, Patient
Updated May 30, 2013. 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.