Data / Medical devices / Taiwan / Wandy Rubber Industrial Co., Ltd
Wandy Rubber Industrial Co., Ltd: FDA-registered device maker in New Taipei City, Taiwan, 5 510(k) clearances
Wandy Rubber Industrial Co., Ltd is registered with the FDA (registration 3003749270) in New Taipei City, Taiwan. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 20, 2013. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3003749270
- Address
- No. 48, Lane 392, Fu De 1st Road Xi-Zhi District, New Taipei City, Taiwan, 22150
- Owner or operator
- Wandy Rubber Industrial Co., Ltd. (9051017)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 18, 2007
- Registered through
- 2026
- Brand names listed
- WANDY, Wandy, Wandy Dispersive Electrode, Wandy Self-Adhesive Electrodes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Iontophoresis, Other Uses | EGJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Electrosurgical Patient Return Electrode | ODR | 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 |
|---|---|---|---|---|---|---|
| December 20, 2013 | K132998 | WANDY SELF-ADHESIVE ELECTRODES | GXY | Substantially Equivalent | Wandy Rubber Industrial Co., Ltd. | accessdata.fda.gov |
| December 20, 2012 | K121268 | WANDY DISPERSVIE ELECTRODE | ODR | Substantially Equivalent | Bio-Med USA, Inc. | accessdata.fda.gov |
| July 10, 2003 | K031174 | BODY SIGNAL ECG ELECTRODE | DRX | Substantially Equivalent | Wandy Rubber Industrial Co., Ltd. | accessdata.fda.gov |
| February 2, 2001 | K002227 | WANDY SILICONE CONDUCTIVE RUBBER PAD | GXY | Substantially Equivalent | Wandy Rubber Industrial Co., Ltd. | accessdata.fda.gov |
| February 2, 2001 | K002219 | WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE | GXY | Substantially Equivalent | Wandy Rubber Industrial Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Iontophoresis, Other Uses
- All makers of Electrode, Electrocardiograph
- All makers of Electrosurgical Patient Return Electrode
- All makers of Electrode, Cutaneous
Updated December 20, 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.