Data / Medical devices / United Kingdom / RGK Wheelchairs, Ltd.
RGK Wheelchairs, Ltd.: FDA-registered device maker in BURNTWOOD Staffordshire, United Kingdom, 2 510(k) clearances
RGK Wheelchairs, Ltd. is registered with the FDA (registration 3003832369) in BURNTWOOD Staffordshire, United Kingdom. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 10, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003832369
- Address
- Units 8 B/C Ring RD 2 Burntwood Business Park, BURNTWOOD Staffordshire, United Kingdom, WS7 3JQ
- Owner or operator
- RGK Wheelchairs Ltd. (9050549)
- Roles
- Manufacturer
- First device listed
- January 13, 2010
- Registered through
- 2026
- Brand names listed
- Octane, Tiga
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| September 10, 2020 | K200135 | RGK Daily Range Wheelchairs | IOR | Substantially Equivalent | Rgk Wheelchairs, Ltd. | accessdata.fda.gov |
| July 12, 2002 | K021075 | MECHANICAL DAILY USE WHEELCHAIR | IOR | Substantially Equivalent | First World Services, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 10, 2020. 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.