Data / Medical devices / United States / Roughrider America LLC
Roughrider America LLC: FDA-registered device maker in Berkeley, CA, United States, 2 510(k) clearances
Roughrider America LLC is registered with the FDA (registration 3011059051) in Berkeley, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 24, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011059051
- Address
- 2233 California St, Berkeley, CA, United States, 94703
- Owner or operator
- RoughRider America LLC (10047144)
- Roles
- Specification developer
- First device listed
- July 7, 2014
- Registered through
- 2026
- Brand names listed
- RoughRider America, RoughRider Aurora, Whirlwind RoughRider, Whirlwind RoughRider Wheelchair, Whirlwind Wheelchair
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wheelchair, Mechanical | IOR | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 24, 2022 | K200715 | RoughRider Aurora Manual Wheelchair | IOR | Substantially Equivalent | Roughrider America, LLC | accessdata.fda.gov |
| January 3, 2011 | K103212 | ROUGHRIDER | IOR | Substantially Equivalent | Whirlwind Wheelchair International | accessdata.fda.gov |
Compare with other makers
Updated June 24, 2022. 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.