FDA Registration
Active
🇺🇸 United States
Whirlwind RoughRider
Reg #: 3011059051
·
FEI: 3011059051
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ROUGHRIDER AMERICA LLC
- Registration Number
- 3011059051
- FEI Number
- 3011059051
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2233 California St
- City
- Berkeley
- State
- CA
- ZIP
- 94703
- Country
- US
Regulatory Submissions
- 510(k) Number
- K103212
Owner / Operator
- Firm Name
- RoughRider America LLC
- Operator Number
- 10047144
- Address
- 2233 California St
- City
- Berkeley
- State
- CA
- Postal Code
- 94703
- Country
- US
- Correspondent
- Marc Krizack
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2014-07-07 |
Proprietary Names
Whirlwind RoughRider
RoughRider America
Whirlwind RoughRider Wheelchair
Whirlwind Wheelchair
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility