Data / Medical devices / Taiwan / Chien Ti Enterprise Co., Ltd.
Chien Ti Enterprise Co., Ltd.: FDA-registered device maker in Taoyuan, Taiwan, 5 510(k) clearances
Chien Ti Enterprise Co., Ltd. is registered with the FDA (registration 3005619729) in Taoyuan, Taiwan. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 2, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005619729
- Address
- No. 833, Changxiang Rd. Jiudou Village, Xinwu Dist., Taoyuan, Taiwan, 327
- Owner or operator
- CHIEN TI ENTERPRISE CO., LTD. (9035328)
- Roles
- Manufacturer, Specification developer
- First device listed
- August 10, 1999
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vehicle, Motorized 3-Wheeled | INI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | 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 |
|---|---|---|---|---|---|---|
| April 2, 2007 | K070602 | C.T.M. MOBILITY SCOOTER# HS-265 | INI | Substantially Equivalent | C.T.M. Homecare Product, Inc. | accessdata.fda.gov |
| March 11, 2003 | K030387 | C.T.M. MOBILITY SCOOTER, MODEL HS-890 | INI | Substantially Equivalent | C.T.M. Homecare Product, Inc. | accessdata.fda.gov |
| August 2, 2002 | K021617 | C.T.M. POWER CHAIR, MODEL HS-2800 | ITI | Substantially Equivalent | C.T.M. Homecare Product, Inc. | accessdata.fda.gov |
| October 24, 2001 | K012792 | C.T.M. MOBITIY SCOOTER MODEL #HS-360 | INI | Substantially Equivalent | Warepalmy Enterprise, LLC (Usa) | accessdata.fda.gov |
| August 25, 2000 | K000356 | C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580 | INI | Substantially Equivalent | Warepalmy Enterprise, LLC (Usa) | accessdata.fda.gov |
Compare with other makers
Updated April 2, 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.