BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED— 510(k) K041025
Substantially EquivalentGolden Technologies, Inc.
FDA 510(k) clearance K041025 for BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED, Substantially Equivalent on 2004-05-03. Applicant: Golden Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Golden Technologies, Inc.
- Product code
- Code INI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3800
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Old Forge, PA, US
Recent devices under product code INI
view allMore clearances from Golden Technologies, Inc.
view allAdverse events under product code INI
product code INI- Injury
- 171
- Other
- 1
- Total
- 172
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K041025
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041025.
Data sourced from openFDA. This site is unofficial and independent of the FDA.