Data / Medical devices / United Kingdom / Wardray Premise Ltd
Wardray Premise Ltd: FDA-registered device maker in Brighouse Leeds, United Kingdom, 1 510(k) clearance
Wardray Premise Ltd is registered with the FDA (registration 3007912863) in Brighouse Leeds, United Kingdom. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 21, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007912863
- Address
- Unit 2, Springvale Works Elland Road, Brighouse Leeds, United Kingdom, HD6 2RN
- Owner or operator
- WARDRAY PREMISE LTD (10030323)
- Roles
- Manufacturer
- First device listed
- November 23, 2009
- Registered through
- 2026
- Brand names listed
- FGTT200 FerroGuard Gurney, MR1501 Fixed Height Trolley, MR1505 Fixed Height Cube Trolley, MR1510 Economy Trolley, MR4500 Folding Portering Chair, MR4501 Fixed Portering Chair, MR5501 Adjustable Height Trolley, MR5501/P Paediatric Elevating Height Trolley and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Examination And Treatment | FRK | 1 | Manufacturer | accessdata.fda.gov |
| Stretcher, Wheeled | FPO | 2 | Manufacturer | accessdata.fda.gov |
| Table, Radiographic, Tilting | IXR | 2 | Manufacturer | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 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 |
|---|---|---|---|---|---|---|
| December 21, 2012 | K120391 | MR4500 WHEELCHAIR | IOR | Substantially Equivalent | Wardray Premise, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Chair, Examination And Treatment
- All makers of Stretcher, Wheeled
- All makers of Wheelchair, Mechanical
- All makers of Table, Radiographic, Tilting
Updated December 21, 2012. 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.