BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED
FDA 510(k) clearance K041025 · decided 2004-05-03
Clearance details
- K-number
- K041025
- Device name
- BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED
- Applicant
- Golden Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-21
- Decision date
- 2004-05-03
- Days to decision
- 12 days
- Clearance type
- Special
- Product code
- INI
- Device class
- 2
- Regulation number
- 890.3800
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Old Forge, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Buzzaround XL scooters' Product Usage: mobility recall (Z-1235-2014) | Golden Technologies, Inc. | 2014-03-20 |