Data / Medical devices / Taiwan / Pihsiang Machinery MFG. Co., Ltd.
Pihsiang Machinery MFG. Co., Ltd.: FDA-registered device maker in HSINCHU COUNTY Hsinchu(County), Taiwan, 6 510(k) clearances
Pihsiang Machinery MFG. Co., Ltd. is registered with the FDA (registration 8043717) in HSINCHU COUNTY Hsinchu(County), Taiwan. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 7, 2014. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 8043717
- FEI number
- 3003792251
- Address
- No. 108,hsin-He Road Hsin Feng Hsiang, HSINCHU COUNTY Hsinchu(County), Taiwan, 304
- Owner or operator
- PIHSIANG MACHINERY MFG. CO., LTD. (9003473)
- Roles
- Manufacturer
- First device listed
- July 2, 1991
- Registered through
- 2026
- Brand names listed
- 888WNLEA3-MPM, 888WNLEA3-MPS, Accessories, COMPONENTS, ROVI A3 888WNLE-5003, ROVI A3 888WNLEA3-MP6-CS, ROVI A3 888WNLEA3-MP6-SS, ROVI X3 888WNLE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Manufacturer | accessdata.fda.gov |
| Components, Wheelchair | KNN | 1 | Manufacturer | accessdata.fda.gov |
| Vehicle, Motorized 3-Wheeled | INI | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 7, 2014 | K142027 | 888 WNLE POWERED WHEELCHAIR | ITI | Substantially Equivalent | Pihsiang Machinery Mfg. Co., Ltd. | accessdata.fda.gov |
| November 19, 2002 | K022539 | PHFW-10 | ITI | Substantially Equivalent | Pihsiang Machinery Mfg. Co., Ltd. | accessdata.fda.gov |
| January 28, 2002 | K013927 | MINI SHOPPER | INI | Substantially Equivalent | Shoprider Intl., Inc. | accessdata.fda.gov |
| November 20, 2001 | K012846 | ZIPPY, MODEL I88WA | ITI | Substantially Equivalent | Pillar Technology, Inc. | accessdata.fda.gov |
| November 16, 2001 | K011473 | SNAZZY2 | INI | Substantially Equivalent | Shoprider Intl., Inc. | accessdata.fda.gov |
| October 30, 2001 | K011476 | SOVEREIGN | INI | Substantially Equivalent | Shoprider Intl., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Vehicle, Motorized 3-Wheeled
- All makers of Wheelchair, Powered
- All makers of Components, Wheelchair
- All makers of Accessories, Wheelchair
Updated October 7, 2014. 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.