Data / Medical devices / Taiwan / Tie Xin Industrial Co., Ltd.
Tie Xin Industrial Co., Ltd.: FDA-registered device maker in Hsien Changhua, Taiwan, 1 510(k) clearance
Tie Xin Industrial Co., Ltd. is registered with the FDA (registration 3010282823) in Hsien Changhua, Taiwan. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 14, 1981. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010282823
- Address
- 29-1, Yongxing St, Ho Hsing Village, Hsien Changhua, Taiwan, 523
- Owner or operator
- Tie Xin Industrial Co., Ltd. (10043139)
- Roles
- Manufacturer
- First device listed
- January 28, 2013
- Registered through
- 2026
- Brand names listed
- BlueRanger MB, BlueRanger WS, DIY Ranger, EconoRanger MB, EconoRanger WS, Neutral Handle Pulley, PinkRanger, Pul-EZ MB and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Traction, Non-Powered | HST | 1 | Manufacturer | accessdata.fda.gov |
| Components, Exercise | IOD | 1 | Manufacturer | accessdata.fda.gov |
| Exerciser, Non-Measuring | ION | 1 | Manufacturer | accessdata.fda.gov |
| Sling, Arm | ILI | 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 |
|---|---|---|---|---|---|---|
| September 14, 1981 | K812351 | NON-MEASURING EXERCISERS | ION | Substantially Equivalent | Fred Sammons, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Components, Exercise
- All makers of Exerciser, Non-Measuring
- All makers of Sling, Arm
- All makers of Apparatus, Traction, Non-Powered
Updated September 14, 1981. 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.