Data / Medical devices / China / Dongguan Tanita Health Equipment Co., Ltd.
Dongguan Tanita Health Equipment Co., Ltd.: FDA-registered device maker in Dongguan City Guangdong, China, 4 510(k) clearances
Dongguan Tanita Health Equipment Co., Ltd. is registered with the FDA (registration 3008262243) in Dongguan City Guangdong, China. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 7, 2009. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008262243
- Address
- Hongtu High Tech Economic Development Zone South City District, Dongguan City Guangdong, China, 523080
- Owner or operator
- TANITA CORP. OF AMERICA (9006383)
- Roles
- Manufacturer
- First device listed
- January 31, 1994
- Registered through
- 2026
- Brand names listed
- BC-1500PRO, BC-401F, BC-603FS, DC-13C, DC-240, DC-240IM, MC-580, RD-545PRO and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition | MNW | 2 | Manufacturer | accessdata.fda.gov |
| Analyzer, Body Composition, Exempt | PUH | 2 | 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 |
|---|---|---|---|---|---|---|
| July 7, 2009 | K090479 | TANITA BODY COMPOSITION ANALYZER, MODEL SC-331 | MNW | Substantially Equivalent | Tanita Corporation of America | accessdata.fda.gov |
| December 23, 2004 | K040778 | TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9) | MNW | Substantially Equivalent | Tanita Corp. of America | accessdata.fda.gov |
| July 22, 2004 | K040978 | TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE | MNW | Substantially Equivalent | Tanita Corp. of America | accessdata.fda.gov |
| June 24, 2002 | K014009 | TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE | MNW | Substantially Equivalent | Tanita Corp. of America | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Body Composition
- All makers of Scale, Stand-On, Patient
- All makers of Analyzer, Body Composition, Exempt
- All makers of Scale, Patient
Updated July 7, 2009. 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.